Final Report Summary - EDCTP-PLUS (EDCTP-Plus: Laying the foundations for the EDCTP-II programme)
Executive Summary:
The purpose of this project was to prepare for an expanded second phase of EDCTP (EDCTP2). EDCTP2 has broadened its scope to include all phases of clinical trials from phase I to IV, Neglected Infectious Diseases (NIDs), and emerging infectious diseases of particular relevance for Africa, including Ebola virus disease (EVD). This expanded scope will include not only working with new diseases, but also new areas of research such as health services optimisation research that will explore how best to deliver the developed intervention tools to those most in need of them. Furthermore, EDCTP2 has changed from a European Economic Interest Group (EEIG) to an Association which allowed for an expanded membership to include African countries and to be open to opportunities to engage in collaboration with other disease endemic countries outside sub-Saharan Africa. The extension into these new areas required a situational analysis and mapping of the needs, capacities, involved stakeholders and potential new partners. Additionally, the project explored the consolidation and enhancement of some of the achievements of the first EDCTP programme such as improving coordination and cooperation among the participating European States, enhanced engagement with the private sector and like-minded organisations, optimal utilisation and retention of the invested capacity, and dissemination of information and advocacy. An independent firm critically assessed the operational processes as well as the coverage and outcomes of the scientific and capacity development activities that were undertaken under the EDCTP1. Lesson learnt and recommendations on areas requiring improvements for EDCTP2 were provided.
The achievements of EDCTP Plus are:
• Publication of the Report Charting Research – EDCTP Participating States programmes and activities in the scope of EDCTP2
• Drafting of a final report on mapping of research programmes and relevant research cooperation activities in the newest EU member States
• Publication of a report on the profiling of the private sector
• Drafting of a strategy and policy to collaborate with third-parties in the second EDCTP programme
• Creation of new reporting templates for EDCTP grant holders and EDCTP Participating States
• Bibliometric analysis of EDCTP research areas in sub-Saharan Africa and Europe and submission of a peer reviewed article titled “Bibliometric assessment of European and sub-Saharan research output on poverty related diseases from 2003 to 2011’ to PLOS NTDs
• Conduct of over 40 key meetings with multinational pharmaceutical firms, CROs, PDPs and other partners (Table 1)
• Successful holding of four (Interim) Scientific Advisory Committee meetings and six thematic stakeholder meetings in 2013 and 2014. These identified EDCTP2 research priorities and informed the EDCTP2 Strategic Business Plan as well as annual work plans
• A meeting on Post-registration medicinal products monitoring in sub-Saharan Africa with private sector and relevant like-minded organisations
• Agreement with the European Federation of Pharmaceutical Industries and Associations to establish a Clinical Research Fellowship Scheme for sub-Saharan Africa
• Selection and development of 24 laboratories (six per EDCTP Network of Excellence) through Stepwise Laboratory Improvement Process Toward Accreditation (SLIPTA) process (Tables 2 and 3)
• Expansion and enhancement of the Pan African Clinical Trials Registry
• Completion of an internal evaluation of the EDCTP ethics programme
• The High-level conference on the second EDCTP programme held in Cape Town
• Two High-level meetings to discuss participation of African countries in EDCTP2
• Revised communication strategy and enhanced visibility of EDCTP2 through an improved website
• Revised standard operating procedures
• Implementation of web-based grant management system (CC Tracker)
• Preparation of comprehensive and more structured financial guidelines for grantees
• The creation of new user-friendly budget and financial reporting forms which were first used for the Strategic Primer Grants (SPGs)
• Introduction of a new due diligence review checklist
• Two project and finance management training workshops in Dakar, Senegal and Johannesburg, South Africa for project coordinators of EDCTP grants
• Improvement of IT infrastructure capability, including IT administrative systems at EDCTP secretariat
• Independent evaluation of EDCTP1 by Technopolis
• Drafting of an operational business plan of EDCTP2.
Project Context and Objectives:
The objectives of the project are:
• To strengthen coordination of existing member states research activities
• To map the existing national programmes on clinical research and development of new tools to address the major poverty-related and NIDs
• To enhance cooperation and synergy with industry, like-minded organisations, non-EDCTP-EEIG member states and other funding agencies and stakeholders working on poverty-related and NIDs
• To strengthen the capacity development, coordination and networking activities undertaken by the current EDCTP programme in coordination with other organisations
• To increase awareness and profile of EDCTP, its achievements and impact including through a high-level meeting involving political representation by all EDCTP stakeholders.
The overall aim of this grant was to prepare for the proposed second phase of the EDCTP programme. In line with this, the following objectives were prioritised:
• Mapping of existing national programmes on clinical research and development of new tools to address the major poverty-related and neglected infectious diseases (NIDS). This included production of a summary and report of EDCTP member states’ national priorities and activities relevant to EDCTP
• Increasing engagement with industry, like-minded organisations, non-EDCTP-EEIG member states, other funding agencies and stakeholders. This was achieved through a series of meetings with key stakeholders to inform them on mechanisms for future collaborations under EDCTP2
• Strengthening of the capacity development and networking activities undertaken by the current EDCTP programme in coordination with other organisations. This included expansion and enhancement of the Pan African Clinical Trials Registry; support for the EDCTP Networks of Excellence to undertake the SLIPTA; internal evaluation of the EDCTP Ethics programme
• Increasing awareness and profile of EDCTP, its achievements and impact prior to the launch of EDCTP2, including the hosting of two high level meetings that engaged political representation by all EDCTP stakeholders and holding the Seventh EDCTP Forum in Berlin, Germany
• Undertake programme review and optimisation of procedures and policies in preparation for the EDCTP2 programme. This included the revision of all grants management related documentation to improve efficiency and to ensure collection of key data for monitoring and evaluation of the performance of individual grants as well as of the EDCTP programme; revision and improvement of audit procedures.
Project Results:
4.1.3.1 High level meeting
The high-level conference on the second EDCTP programme was held in Dakar, Senegal in October 2013. This meeting marked an important step in the consultation of African and international stakeholders on the second programme. The meeting provided a forum to discuss stakeholders’ needs, opportunities and expectations in EDCTP2. It also aimed to raise additional public and private engagement, and support to EDCTP activities. This report is now published on EDCTP website.
4.1.3.2 Collaboration with private sector and product development partners
Strong foundations for future EDCTP collaboration with the private sector and Product Development Partnerships have been established. Key events such as the meeting ‘Post-Registration Medicinal Products Safety Monitoring in sub-Saharan Africa’, the high-level conference, individual meetings with stakeholders indicate opportunities and enthusiasm for mutually productive collaborations under EDCTP2 were completed. An agreement between EDCTP and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to create a joint fellowship programme under EDCTP2 was signed.
To strengthen collaboration with pharmaceutical companies and other third-party organisations including Product Development Partnerships (PDPs), Pharmaceutical companies, non-EDCTP partner countries, other funding agencies, and like-minded organisations working on PRNIDs, the EDCTP Secretariat organised meetings with partners to discuss potential areas of collaboration (Table 1).
4.1.3.3 Developing integration and funding strategies: mapping of and cooperation between national programmes
The aim of this objective was to map European and African countries’ national programmes and activities within the anticipated scope of EDCTP2 to determine research priorities for malaria, HIV, tuberculosis, NIDs and health services optimisation research as well as to establish baseline data on research activities and funding for research of European participating States and African Partner Countries to assess subsequent impact of EDCTP2. RAND Europe was contracted in month 13 to conduct a mapping analysis of the landscape of health research for poverty-related and neglected infectious diseases (PRNIDs) and national funding commitments in sub-Saharan Africa. The report included desk based reviews of health research publications (globally), and a fieldwork exercise in 46 sub-Saharan African countries that was sub-contracted to Baird’s CMC. Discussions on how to build synergies with other relevant initiatives and activities were held with other bodies and funders such as ESSENCE, COHRED and DSW. The results of the projects were presented during the 7th EDCTP Forum in Berlin, Germany and RAND, BAIRD’s CMC and EDCTP jointly published a high level report on the outcomes of the project. This report was distributed during the 7th EDCTP Forum and was made publically available on the website of the three organisations that authored the report.
4.1.3.4 Bibliometrics
As part of the mapping project this component was contracted in month 13 to Thomson Reuters Evidence, a firm specialised in bibliometric citation analysis. The objective of the study was to quantify research outputs of European and African researchers in the above mentioned research areas, identify leading institutions and researchers in these fields, and describe collaboration patterns at a country and institutional level. The bibliometric analysis and other mapping activities contribute to informing the scope and strategy for EDCTP2 and to enable future analysis to measure impact of the programme. The project also strengthened EDCTP’s future analysis of publications arising from EDCTP-funded research. A final report was submitted i and results were also presented at the Seventh EDCTP Forum. A peer-reviewed article summarising the findings of this research was submitted to PLOS Neglected Tropical Diseases on 17 November 2014 and is still under review (see Template 1A). Furthermore, Thomson Reuters Evidence performed a supplementary analysis on the newest EU Member States and their collaborations with other European countries based on research outputs. The analysis quantified research collaboration between two groupings of European countries: EU-12 plus Croatia and the EU-15 plus Norway and Switzerland, between 2003 and 2011. The report was completed.
4.1.3.5 Mapping of research programmes and relevant research cooperation activities in the newest EU member States
The country profiles of Finland and EU-12 plus Croatia were also finalised and included in a separate report titled “Full report of European EDCTP partner countries’ national programmes and activities: Newer European Union Member States and Finland”
4.1.3.6 Preparation of a new template for reporting of EU EDCTP partner countries’ funding and activities for EDCTP2
A template was developed for Participating States to report on national activities (‘PSIAs’) to be included in the EDCTP annual work plan. This template formed the basis to develop the online portal in the grants management system CC Tracker for General Assembly (GA) members to report on activities included in their national annual work plans.
4.1.3.7 Profiling of EDCTP partner countries and other activities to foster cooperation and integration of EDCTP partner countries activities and programmes
To accomplish this activity the following actions were implemented:
• Dedicated mailings and targeted telephone conferences with current EDCTP partner countries that were less active in 2013 (i.e. Ireland, Greece, Luxembourg, Portugal)
• Invitations sent to representatives from 12 newly joined European countries to attend a webinar on EDCTP in 2013
• Invitations sent to partner countries and prospective partner countries to attend EDCTP stakeholder meetings (attendance from Lithuania, Croatia, Latvia) and Seventh EDCTP Forum in 2013
• Consultation with EDCTP partner countries regarding research priorities throughout 2013 for completion of Participating States work plans
• Identification of MS funding to product development partnerships (PDPs) and related activities that could be included in the EDCTP-II work plan in 2013
• Participation in networking events to promote EDCTP to representatives of EU-13 (e.g. booth at Open Info Day on Horizon 2020) in 2014
• Compilation of dedicated mailings and targeted telephone conferences with EDCTP Participating States that were less active in 2014 (i.e. Ireland, Greece, Luxembourg). All the EDCTP1 European partner countries, except for Greece and Belgium, confirmed their participation in EDCTP2 and had indicated their in-kind and/or cash commitments
• Face to face meetings in the Hague with Ireland and the UK to provide an overview of the new funding mechanisms under EDCTP2 and to discuss the requirements for the annual country specific work plans in order to better align the research objectives of the national institutions in 2014
• Invitations to partner countries and prospective partner countries to attend EDCTP stakeholder meetings (attendance from Lithuania, Croatia, Latvia) and Seventh EDCTP Forum in 2014
• Consultation with EDCTP partner countries regarding research priorities throughout 2014 for completion of Participating States (PSs) annual work plans for 2014 and 2015
• Identification of PS funding to product development partnerships (PDPs) and related activities that could be included in the EDCTP2 work plan
• Participation in networking events to promote EDCTP to representatives of EU-13
o Submission of an abstract of EDCTP2 programme presented at the 11th Annual Conference of the Baltic Network Against Life-threatening Viral Infections in Vilnius, Lithuania, on 24-27 April 2014
o Attendance at information day on the EDCTP2 programme in Prague, jointly organised by the Czech Ministry of Education, Youth and Sports and the Technology Centre of the Academy of Sciences of the Czech Republic (ASCR) on 26 March 2014
• Contact with PS to raise funds for the Seventh EDCTP Forum
• Regular contact with PSs to compile national work plans in 2014.
4.1.3.8 Identification of future research priorities
Four Scientific Advisory Committee meetings and six stakeholder meetings took place and discussed EDCTP future research priorities that informed updating of EDCTP Strategic Business Plan and preparation of annual work plans. The Secretariat played an active role in these meetings and prepared the necessary background documents and briefing material.
4.1.3.9 EDCTP-EFPIA Fellowship Scheme
Following meetings with WHO-TDR in September 2013, EDCTP and WHO-TDR on 27 March 2014 signed a Letter of Collaboration to jointly implement a fellowship scheme for scientists and clinical staff from low-and middle-income countries (LMICs). This partnership will strongly enhance the work which each organization has in common and thereby strengthen research capacity in developing countries. A larger number of scientists and clinical staff will be trained, resulting in an increased impact on research and development capacity in LMICs. The partnership will ensure synergies between the different parties involved, and will facilitate common communication with researchers, pharmaceutical companies and home institutions. This fellowship scheme will be launched annually and the first Call for proposals was launched on 31 October 2014. In total 20 organisations (pharmaceutical companies and product development partnerships (PDPs) participated to this first call and agreed to host one or more fellows for a duration of up to two years.
4.1.3.10 Scholarships for MSc programme in vaccinology in Siena, Italy
Six scientists among fifteen training awardees from sub-Saharan Africa involved in EDCTP-funded vaccine development projects successfully defended their thesis at the University of Siena on 17 November 2014 and were presented with the Master certificate in Vaccinology and Pharmaceutical Clinical Development. In 2015, the 4th Master Course in vaccinology will commence and six candidates from sub-Saharan Africa have been shortlisted. The final selection of candidates will be made by the university in February 2015. The objective of the Master’s programme is to build capacity in vaccinology and vaccine development in developing countries. The Master’s programme is offered by the University of Siena Medical School, Novartis Vaccines and Diagnostics, Novartis Vaccines Institute for Global Health (NVGH), and ADITEC (Advanced Immunization Technologies).
4.1.3.11 Collaboration with the Bill & Melinda Gates Foundation (BMGF)
In 2013 EDCTP Secretariat discussed with BMGF the plans for jointly funding a Randomized Clinical Trial of the Effects of Progestin-Only Contraception and the Copper Intrauterine Device (IUD) on the Risk of HIV Acquisition in Young Women (Echo Trial). A follow-up meeting took place at the EDCTP HIV stakeholder meeting on 3 September 2013. In January 2014, EDCTP was approached by the Bill and Melinda Gates Foundation and the National Institutes of Health (NIH) to enquire about EDCTP’s potential interest to participate in the joint funding of the Global TB Alliance’s STAND trial (NC-006) (Shortening Treatment by Advancing Novel Drugs). This is a multi-centre clinical trial to evaluate the efficacy, safety and tolerability of the combination of moxifloxacin plus PA-824 plus pyrazinamide (the M-Pa-Z regimen). Apart from aiming to shorten treatment with drug-sensitive patients, the M-Pa-Z regimen also offers the promise of improved cure rates for MDR-TB patients. The potential funders group, which included members of the Gates Foundation, NIH and EDCTP held monthly teleconferences throughout 2014 about the progress of securing funding for the STAND trial. It is expected that the trial will be launched in 2015.
4.1.3.12 CASPA Initiative
In 2013, EDCTP facilitated the organisation of a breakfast meeting together with PATH Malaria Vaccine Initiative (MVI), Medicines for Malaria Venture (MMV) and GlaxoSmithKline Vaccines for potential donors of the CASPA Initiative. EDCTP together with the EDCTP Participating States, the European Commission, the European Federation of Pharmaceutical Industries and Associations, GSK and Sanofi also organised a lunch meeting during the Seventh EDCTP Forum to explore opportunities to develop an effective and sustainable pharmacovigilance platform in sub-Saharan Africa. The overall objective of this meeting was to bring together interested stakeholders and to define next steps for the creation of such platform.
4.1.3.13 Global TB Vaccine Partnership (GTBVP)
In 2013, EDCTP started discussion with the Global TB vaccine Partnership to consider broader EU Member States participation in the GTBVP, which would strengthen EU leadership in TB vaccine development. During 2014, EDCTP attended multiple telephone conference and face to face meetings of the working group and facilitated the organisation of a satellite meeting by the working group during the Seventh EDCTP forum in Berlin. The GTBVP will be looking into the best incorporation options for an eventual GTBVP legal entity.
4.1.3.14 Calouste Gulbenkian Foundation
During the Seventh EDCTP Forum EDCTP and representatives of the Gulbenkian Programme Partnerships for Development decided to collaborate to support sub-Saharan African countries in developing a robust ethical and regulatory framework for conducting clinical trials. The Gulbenkian Foundation will provide cofunding to support successful applications from Portuguese speaking African countries to Calls for Proposals launched by EDCTP to strengthen ethics and regulatory capacities in sub-Saharan Africa. This collaboration was formalised during collaboration signing ceremony in Lisbon on 9 March 2014.
4.1.3.15 Development Agencies
To increase the impact of EDCTP2 effective cooperation with relevant EU initiatives, including its development assistance the EDCTP GA decided to reconvene a Development Cooperation working group and this group held several telephone conferences. On 13 February 2015 a meeting will be scheduled in The Hague to provide an opportunity for an informal information exchange between EDCTP and representatives from some of the key European development cooperation agencies to explore pragmatic strategies and ways to collaborate. The meeting is expected to result in the identification and prioritisation of areas on which to jointly fund or coordinate the funding of activities and an agreed way forward for better engagement with one another. Feedback and recommendations will also be sought on the plans and preparations for a possible follow-on meeting with a larger group of development cooperation agencies and other relevant stakeholders, to be hosted by DG DEVCO in Brussels in 2015.
4.1.3.16 Cooperation with other agencies
In addition to activities mentioned above EDCTP Secretariat participated in monthly telephone conferences with AREAS in order to be updated on AERAS development pipeline and to inform then about the new funding mechanisms under EDCTP2. It also participated in a telephone conference and held face to face meeting with representative of Bioventures for Global Health.
4.1.3.17 Joint Activities with third-parties
The legislative proposal for EDCTP2 provided the opportunity to “launch joint calls with third countries or their scientific and technological organisations and agencies, with international organisations or with other third parties, in particular non-governmental organisations”. Joint Activities with third-parties will provide an opportunity for EDCTP to partner with other major funders and to support an activity that is strategically important to EDCTP but too large to be covered in full by EDCTP alone. EDCTP Secretariat updated the strategy and rules of engagement with third-parties, including transparent engagement rules and an outline of the different funding modalities in EDCTP2 to increase private sector collaborations and potential joint calls. This document guides the participation of third-parties in EDCTP2.
4.1.3.18 Support for continuation of EDCTP funded regional Networks of Excellence
The four EDCTP funded regional NoEs are Central Africa Network for TB, AIDS and malaria (CANTAM), East African Consortium for Clinical Research (EACCR), Trials of Excellence for Southern Africa (TESA) and West African Network for TB, AIDS and malaria (WANETAM). As part of CSA grant, these NoEs received support to upgrade capacity under the following categories: (1) information and computer technology infrastructure upgrade for improving communication within and across the networks; (2) short-term training activities, uniquely prioritised by each individual network; (3) development of laboratories selected by the NoEs in preparation for future internationally recognised accreditation (coordinated directly by EDCTP Secretariat) and (4) financial and project management as a mandatory requirement for all NoEs. The fourth category was a universal capacity gap identified by and coordinated directly by the EDCTP Secretariat.
4.1.3.19 Information and computer technology infrastructure upgrade
All four NoEs benefited with improvement of ICT facilities for use within and across the networks. These improvements included facilities like VoIP (Voice over Internet Protocol) and NAS (Network Attached Storage) system for backups and file sharing, installation of video conference systems, American Power Conversion (APC) smart central uninterruptible power supply (UPS), new computers, printers and appropriate software. Besides potential reduction for future travel costs, such improvements are also aimed at enabling NoE to prepare for activities like E-learning platforms, biobanking and database management.
4.1.3.20 Short term trainings
In TESA three short-term training courses on tuberculosis and eight crosscutting issues were conducted. The Spoligotyping and mycobacteria interspersed repetitive unit (MIRU) Diagnostic Techniques workshop prepared participants for the analysis and typing of TB-MDR/XDRTB genome for multisite clinical trials and biomarker studies of tuberculosis. In addition the clinical pharmacokinetic-pharmacodynamic (PK/PD) research training resulted in an immediate output where attendees could prepare a protocol outline for their own PK/PD clinical research studies. 107 staff were trained in cross cutting courses that included:
• Project management for clinical staff
• Good Clinical Practice (GCP) training of trainers
• Good Clinical and Laboratory Practice (GCLP) training of trainers
• Full International Air Transport Association (AITA) training in handling dangerous research products
• Refresher IATA training
• Intermediate biostatistics
• Scientific writing
• Clinical PK/PD for HIV/TB/malaria.
In EACCR cross-sectional workshops trained 75 staff in courses that included:
• TB epidemiology and microbiology
• Integrated management of TB-HIV infection
• HIV guidance and counselling
• GCLP training
• Research management
• TB/HIV co-infection management
• Mentoring and cross-site clinical trials monitoring.
EACCR also successfully implemented a reciprocal monitoring scheme, an innovative in-house strategic quality management tool for the EACCR clinical trials. The scheme led to the mentorship of 13 new monitors by 12 experience regional monitors and also managed to attract and facilitate participation of 1 new Rwandese partner. TB techniques training via mentorship laboratory attachment was provided to several laboratory technologists. The areas covered in the training 24 staff were:
• Epidemiology
• GCLP and a visit to the Institute of Endemic Diseases clinical trial site in Sudan
• Qualitative culture training
• ISO15189:2007 training
HIV-related mentorship training was provided to 8 HIV/AIDS node members. The members were trained on use of Nvivo 8 software to analyse, interpret and report qualitative research data. Other courses included ethics.
In WANETAM HIV and Tuberculosis workshops trained 32 staff. The disease specific training included:
• Mass spectrophotometry
• Drug sensitivity testing for first and second line anti-TB drugs
• Molecular phylogeny
• Advanced molecular phylogeny
• HIV resistance, quality assurance and data management
• Microbiology
• University diploma in retrovirology
• ARV resistance testing.
Crossing cutting training for 65 staff included the following topics:
• Applied Elispot and flow cytometry
• International monitoring and evaluation
• Monitoring and evaluation
• Project development and grant writing
• Clinical trials short course
• Project costs management
• Laboratory accreditation preparation in three parts: (i) risk and chemical dangers, (ii) knowledge management of non-conformities, (iii) mastery of measurement of process
• MS project planning
• Quality control
• Advanced excel stock management
• Project Management Professional
• Procurement and purchasing
• Monitoring and evaluation training to enhance the knowledge of a few WANETAM members as internal quality control and network evaluation resource persons. Database creation and management using Access computer programme
• STATA training to strengthen capacity for statistical analysis of data collected within the scientist network.
In CANTAM disease specific training for 61 staff contained:
• TB culture, drug sensitivity testing, quality control and bio-safety
• Genotyping and mutational methods
• TB clinical trials
• Standardisation of ELISA analyses
• In vitro culture of plasmodium falciparum and drug sensitivity testing
• Standardisation of PCR based parasite genotyping
• Drug resistance and viral load determination for mother to child transmission.
Cross-cutting training involving 90 staff included the following topics:
• Workshop for ethics committees and investigators
• Clinical data management in TB and malaria
• Biostatistics
• Online and on-site epidemiology
• Neglected Infectious Diseases (NIDs) molecular detection
• GCP.
4.1.3.21 Financial management training
Through EDCTP-Plus 34 project managers and investigators were trained in finance and project management. Of these 15 were trained in Dakar between 26 and 27 June 2013 while 19 were trained in Johannesburg between 16 and 17 July 2013. The objective of these workshops was to provide participants with the required knowledge and project management skills necessary for them to improve project management at their respective institutions. Topics covered included:
• Auditing
• Budgeting preparation and negotiation
• Cash management
• Purpose and objective of internal controls
• Fraud and Error
• Financial statements
• EDCTP financial guidelines:
o Accounting policies
o EDCTP budgeting rules
o No cost extensions
o Cofounding
o Disbursement procedures
o Foreign exchange risk
o Accounting for overheads
o Eligible and ineligible costs
• Bribery Act and Anti-Corruption
• Project Management in EDCTP projects
• Project Management - Key terms & Process
• Project management tools and techniques
• Creating a Clinical Trials Project Plan
• Managing the Plan
• Reporting progress
• Project risk management.
Post-training evaluation shows that attendees found the workshop useful; and they are convinced that the knowledge they have acquired will help them to strengthen project management at their different institutions.
4.1.3.22 Laboratory upgrades towards accreditation
Twenty four laboratories (six per NoE), were selected for Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA). These laboratories are located in 18 sub-Saharan African countries: Burkina Faso, Cameroon, Congo, Ethiopia, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, Senegal, South Africa, Sudan, Tanzania, The Gambia, Uganda, Zambia and Zimbabwe. Initial assessment of all 24 laboratories was completed in 2013 by LQT. Table 2 shows the number of laboratories under each rating within each NoE. Through a selective tender process, the African Society of Laboratory Medicine (ASLM) and Quintiles were identified as suitable firms for mentoring the selected laboratories. ASLM was allocated 16 laboratories with a star rating of zero to 2 based on SLIPTA scale, while Quintiles was allocated the remaining 8 laboratories with stars rating 3 and above, based on SLIPTA scale.
The laboratories are in the process of implementing the ongoing corrective actions and closing identified gaps.
By the end of 2014, three out of 24 laboratories namely MRC-Gambia, MRC-UVRI and University Cheikh Anta DIOP (LBV) had applied for accreditation.
The overview of laboratories by end of 2014 is summarised in the table below.
4.1.3.23 Support to Pan African Clinical Trials Registry (PACTR)
The CSA grant supported expansion of the registry remit to accept all clinical trials (I-IV) including pharmacodynamics and pharmacokinetic studies; supporting completion of registry upgrading activities which included debugging of the current database, portal maintenance and portal optimisation to comply with the new minimum standards for the WHO Trial Registration Data Set (TRDS); supporting progression to Phase IV development developments. Phase IV developments of the registry which include development of partner registry capabilities, supporting improvement of search functionality, linking of publications by trialists and supporting further development of the registry’s data management including user friendly search functions capacity that permit users to save search results as well as the creation of discussion forums.
The deliverables that have been achieved by PACTR as of end of 2014 were as follows:
• 24 trial information transfers have been submitted to WHO International Clinical Trials Search Platform in order to maintain WHO status
• 20 working group meetings have been held. These consultative technical meetings are through teleconferences and involve advisors from Liverpool School of Tropical Medicine, Australian national clinical trials registry, WHO headquarters and Africa regional office, Africa Vaccine Regulators Forum (AVAREF), South African national clinical trials registry and the Medical Research Council of South Africa. These technical meetings have shaped and delivered a 5-10 year strategic business plan for PACTR that includes a sustainability strategy.
• 7 lectures have been conducted to actively promote PACTR and clinical trial registration within the African region
• 3 publications have been developed and published in reputable peer reviewed journals
• PACTR launched a call to Regional Regulatory Authorities to partner with them. Two potential partners have been selected and are in the final stages of receiving approval from WHO for official partnerships. The pilot testing of the process of partnering is enabling the possibility of partnering with many other national registries. PACTR has facilitated a face-to-face training and engagement with the Ugandan National Regulatory Authority to discuss the structure, function and processes of clinical trial registration and partnering
• The Geographic Information Systems (GIS) component was launched and is continually updated as trials are registered to reflect a real-time picture of the registry’s content. The website was revamped so that the look and feel of the site is more contemporary and accessible.
• Phase IV database development was completed and included streamlining administrative functions, thereby improving search functions and ensuring that the database and related registry web-pages are improved.
There has been an exponential growth in the number of trial registrations in PACTR (Figure 1).
4.1.3. 24 Implementation of a new, improved grants management system with updated grants management policies, procedures and processes in preparation for the anticipated expanded scope and scale of EDCTP2.
The EDCTP Code of Conduct and Declaration of Interests Policy was drafted and approved by the GA. The policy applies to reviewers, members of EDCTP governance bodies (i.e. GA and SAC), staff members and contractors. Declaration of interest forms have been revised in line with the policy. Revision and update of application forms for Integrated Projects and Fellowships were accomplished. The forms were revised to ensure compliance with the H2020 rules for participation. A new final report form for EDCTP’s Integrated Projects and Member States Initiated Projects was released. The new format has facilitated collection of outputs and indicators on EDCTP achievements. The reviewer assessment form for final reports was updated in accordance with the new report format. Revision of EDCTP Standard Operating Procedures (SOPs) was completed. The SOPs reflect the new working arrangements in line with the Rules for Participation of Horizon 2020 and the introduction of an electronic grants management.
An online system for recruitment of expert reviewers will be finalized and introduced on the new EDCTP website. The preliminary system will consist of a hyperlink on the EDCTP website which opens a registration form that will allow potential expert reviewers to register themselves as potential experts. An electronic grants management system (CC Tracker) is operational. An expanded database of reviewers will be an integrated module of the electronic grants management system.
4.1.3.25 Evaluation of EDCTP1 programme
EDCTP1 external evaluation was undertaken and completed by the firm Technopolis BV. Amsterdam, the Netherlands.
4.1.3.26 Strengthening of EDCTP site evaluation and audit procedures by adoption and piloting of a common financial audit framework developed in partnership with other funding agencies
During the CSA period EDCTP has been working with members of the International Financial Governance Consortium (IFGC) to develop common approach to dealing with some of the financial management capacity challenges of conducting clinical trials in sub-Saharan Africa. The formed International Financial Governance Consortium has worked together to develop a Financial Management Assessment Tool (FMAT) that will be used to assess the financial management capacity of new sites. Two reports have been published in two newsletters and shared with third parties.
4.1.3.27 Financial audits
The following sites were audited by PWC Netherlands in 2013:
• Makerere University
• Uganda Virus Research Institute (UVRI)
• Centre Hospitalier Universitaire Aristide Le Dantec
• Academisch Medisch Centrum (AMC)
• Université Cheikh Anta Diop (UCAD)
• University of Zimbabwe Clinical Research Centre (UZCRC)
These sites were selected based on the following selection criteria:
• Actual expenditure more than €250,000
• End date of the project is not within the next 12 months
• Projects with many Grant Finance Officer observations in previous financial reports
• Sites with more than one EDCTP funded project
• Previous unfavourable site visit reports
• Sites with high staff turnover in the finance department.
In addition to the external audits by PWC, three site visits were carried out by the Secretariat to review the financial management systems and procedures. These included a review of the following:
• Bank reconciliation statements to ensure that bank reconciliations are performed and reviewed on a regular basis
• Financial transaction documents
• Fixed asset registers
• Payroll reports
• Extent of compliance with EDCTP financial guidelines
• Overall financial and internal control systems.
4.1.3.28 Development of a new, improved integrated information management system
The following objectives have been achieved in this area:
• Purchase of essential hardware to ensure the security, back up and long term storage of EDCTP systems and data
• Data cleaning and data entry into the new project database. Design and finalisation of database fields for collection of key project data
• Fixed asset register module was purchased and implemented. This has improved the system of custodial control over assets. These include computers, office equipment and other assets
• Sage HR module was purchased and implemented. This has improved the management of HR records
• Development of an operational information system that integrates the accounting and project databases into a single system with full access and functionality for EDCTP staff in the Africa and Europe offices
• Implementation of an electronic grants management system.
4.1.3.29 EDCTP2 work plan
The first draft of the EDCTP work plan, which describes the activities to be implemented during the first two years (2014-2015) of the new programme, was written in November 2013 and presented to the EDCTP Interim SAC and the EDCTP GA in December 2013. After several revisions the work plan was approved by the EC in December 2014 and the GA in January 2015.
Potential Impact:
4.1.4.1 High level meeting
The high-level conference on the second EDCTP programme which included discussions on stakeholders’ needs, opportunities and expectations in EDCTP2 increased knowledge about the programme and stimulated participation of Africa countries in the second phase of the programme. The 2014 member states work plans show substantial in-kind and cash contributions from both African and European member states. The report of this conference is published on EDCTP website.
4.1.4.2 Collaboration with private sector and product development partners
Numerous meetings were conducted to enforce EDCTP collaboration with the private sector and Product Development Partnerships. This has brought on board pharmaceutical companies and other third-party organisations including Product Development Partnerships (PDPs), Pharmaceutical companies, non-EDCTP partner countries, other funding agencies, and like-minded organisations to potentially partner EDCTP in funding the second programme. Publications of meeting reports and key invents like signing of memorandum of understanding were published on the EDCTP website.
4.1.4.3 Developing integration and funding strategies: mapping of and cooperation between national programmes
Mapping European and African countries’ national programmes and activities within the anticipated scope of EDCTP2 to determine research priorities for malaria, HIV, tuberculosis, NIDs and health services optimisation research as well as to establish baseline data on research activities and funding for research of European participating States and African Partner Countries potentially increased knowledge among EDCTP2 member states and its partners. A mapping report was produced and is downloadable from the EDCTP website.
4.1.4.4 Bibliometrics
The bibliometric analysis and other mapping activities potentially contributed to increased knowledge about the scope and strategy for EDCTP2 and enabled future analysis to measure impact of the programme. The project also strengthened EDCTP’s future analysis of publications arising from EDCTP-funded research. Results have been accepted for publication in an international journal.
4.1.4.5 EDCTP-EFPIA Fellowship Scheme and Scholarships for MSc programme in vaccinology in Siena, Italy
Implementing these training programmes has increased collaboration between pharmaceutical companies, product development partnerships (PDPs), WHO-TDR and EDCTP. This will potentially increase the flow of third party funding to EDCTP2 activities.
4.1.4.6 Support for continuation of EDCTP funded regional Networks of Excellence
Support to the four EDCTP funded regional NoEs has improved scientific, information and computer technology infrastructure within the networks. These activities potentially added to the economic activities in the countries involved as most of the materials were locally purchased. Several trainings also provided employment to the trainers and their institutions.
4.1.4.7 Support to Pan African Clinical Trials Registry (PACTR)
The expansion of the functions of PACTR has resulted in increased capacity to record and present clinical trials in Africa. This is an important resource to scientists, regulators, policy makers and other EDCTP partners. PACTR presents a pool of knowledge to such beneficiaries including meta-analysis of collected studies for generating evidence for policy.
4.1.4.8 EDCTP2 work plan
The EDCTP work plan has provided a framework and guidance for implementing EDCTP2. Member states’ activities and contributions are presented in the plan. This potentially contributes to synergy of member states’ efforts and better understanding of the partners to the programme. The work plan was approved by the EC in December 2014 and the GA in January 2015.
List of Websites:
www.edctp.org
The purpose of this project was to prepare for an expanded second phase of EDCTP (EDCTP2). EDCTP2 has broadened its scope to include all phases of clinical trials from phase I to IV, Neglected Infectious Diseases (NIDs), and emerging infectious diseases of particular relevance for Africa, including Ebola virus disease (EVD). This expanded scope will include not only working with new diseases, but also new areas of research such as health services optimisation research that will explore how best to deliver the developed intervention tools to those most in need of them. Furthermore, EDCTP2 has changed from a European Economic Interest Group (EEIG) to an Association which allowed for an expanded membership to include African countries and to be open to opportunities to engage in collaboration with other disease endemic countries outside sub-Saharan Africa. The extension into these new areas required a situational analysis and mapping of the needs, capacities, involved stakeholders and potential new partners. Additionally, the project explored the consolidation and enhancement of some of the achievements of the first EDCTP programme such as improving coordination and cooperation among the participating European States, enhanced engagement with the private sector and like-minded organisations, optimal utilisation and retention of the invested capacity, and dissemination of information and advocacy. An independent firm critically assessed the operational processes as well as the coverage and outcomes of the scientific and capacity development activities that were undertaken under the EDCTP1. Lesson learnt and recommendations on areas requiring improvements for EDCTP2 were provided.
The achievements of EDCTP Plus are:
• Publication of the Report Charting Research – EDCTP Participating States programmes and activities in the scope of EDCTP2
• Drafting of a final report on mapping of research programmes and relevant research cooperation activities in the newest EU member States
• Publication of a report on the profiling of the private sector
• Drafting of a strategy and policy to collaborate with third-parties in the second EDCTP programme
• Creation of new reporting templates for EDCTP grant holders and EDCTP Participating States
• Bibliometric analysis of EDCTP research areas in sub-Saharan Africa and Europe and submission of a peer reviewed article titled “Bibliometric assessment of European and sub-Saharan research output on poverty related diseases from 2003 to 2011’ to PLOS NTDs
• Conduct of over 40 key meetings with multinational pharmaceutical firms, CROs, PDPs and other partners (Table 1)
• Successful holding of four (Interim) Scientific Advisory Committee meetings and six thematic stakeholder meetings in 2013 and 2014. These identified EDCTP2 research priorities and informed the EDCTP2 Strategic Business Plan as well as annual work plans
• A meeting on Post-registration medicinal products monitoring in sub-Saharan Africa with private sector and relevant like-minded organisations
• Agreement with the European Federation of Pharmaceutical Industries and Associations to establish a Clinical Research Fellowship Scheme for sub-Saharan Africa
• Selection and development of 24 laboratories (six per EDCTP Network of Excellence) through Stepwise Laboratory Improvement Process Toward Accreditation (SLIPTA) process (Tables 2 and 3)
• Expansion and enhancement of the Pan African Clinical Trials Registry
• Completion of an internal evaluation of the EDCTP ethics programme
• The High-level conference on the second EDCTP programme held in Cape Town
• Two High-level meetings to discuss participation of African countries in EDCTP2
• Revised communication strategy and enhanced visibility of EDCTP2 through an improved website
• Revised standard operating procedures
• Implementation of web-based grant management system (CC Tracker)
• Preparation of comprehensive and more structured financial guidelines for grantees
• The creation of new user-friendly budget and financial reporting forms which were first used for the Strategic Primer Grants (SPGs)
• Introduction of a new due diligence review checklist
• Two project and finance management training workshops in Dakar, Senegal and Johannesburg, South Africa for project coordinators of EDCTP grants
• Improvement of IT infrastructure capability, including IT administrative systems at EDCTP secretariat
• Independent evaluation of EDCTP1 by Technopolis
• Drafting of an operational business plan of EDCTP2.
Project Context and Objectives:
The objectives of the project are:
• To strengthen coordination of existing member states research activities
• To map the existing national programmes on clinical research and development of new tools to address the major poverty-related and NIDs
• To enhance cooperation and synergy with industry, like-minded organisations, non-EDCTP-EEIG member states and other funding agencies and stakeholders working on poverty-related and NIDs
• To strengthen the capacity development, coordination and networking activities undertaken by the current EDCTP programme in coordination with other organisations
• To increase awareness and profile of EDCTP, its achievements and impact including through a high-level meeting involving political representation by all EDCTP stakeholders.
The overall aim of this grant was to prepare for the proposed second phase of the EDCTP programme. In line with this, the following objectives were prioritised:
• Mapping of existing national programmes on clinical research and development of new tools to address the major poverty-related and neglected infectious diseases (NIDS). This included production of a summary and report of EDCTP member states’ national priorities and activities relevant to EDCTP
• Increasing engagement with industry, like-minded organisations, non-EDCTP-EEIG member states, other funding agencies and stakeholders. This was achieved through a series of meetings with key stakeholders to inform them on mechanisms for future collaborations under EDCTP2
• Strengthening of the capacity development and networking activities undertaken by the current EDCTP programme in coordination with other organisations. This included expansion and enhancement of the Pan African Clinical Trials Registry; support for the EDCTP Networks of Excellence to undertake the SLIPTA; internal evaluation of the EDCTP Ethics programme
• Increasing awareness and profile of EDCTP, its achievements and impact prior to the launch of EDCTP2, including the hosting of two high level meetings that engaged political representation by all EDCTP stakeholders and holding the Seventh EDCTP Forum in Berlin, Germany
• Undertake programme review and optimisation of procedures and policies in preparation for the EDCTP2 programme. This included the revision of all grants management related documentation to improve efficiency and to ensure collection of key data for monitoring and evaluation of the performance of individual grants as well as of the EDCTP programme; revision and improvement of audit procedures.
Project Results:
4.1.3.1 High level meeting
The high-level conference on the second EDCTP programme was held in Dakar, Senegal in October 2013. This meeting marked an important step in the consultation of African and international stakeholders on the second programme. The meeting provided a forum to discuss stakeholders’ needs, opportunities and expectations in EDCTP2. It also aimed to raise additional public and private engagement, and support to EDCTP activities. This report is now published on EDCTP website.
4.1.3.2 Collaboration with private sector and product development partners
Strong foundations for future EDCTP collaboration with the private sector and Product Development Partnerships have been established. Key events such as the meeting ‘Post-Registration Medicinal Products Safety Monitoring in sub-Saharan Africa’, the high-level conference, individual meetings with stakeholders indicate opportunities and enthusiasm for mutually productive collaborations under EDCTP2 were completed. An agreement between EDCTP and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to create a joint fellowship programme under EDCTP2 was signed.
To strengthen collaboration with pharmaceutical companies and other third-party organisations including Product Development Partnerships (PDPs), Pharmaceutical companies, non-EDCTP partner countries, other funding agencies, and like-minded organisations working on PRNIDs, the EDCTP Secretariat organised meetings with partners to discuss potential areas of collaboration (Table 1).
4.1.3.3 Developing integration and funding strategies: mapping of and cooperation between national programmes
The aim of this objective was to map European and African countries’ national programmes and activities within the anticipated scope of EDCTP2 to determine research priorities for malaria, HIV, tuberculosis, NIDs and health services optimisation research as well as to establish baseline data on research activities and funding for research of European participating States and African Partner Countries to assess subsequent impact of EDCTP2. RAND Europe was contracted in month 13 to conduct a mapping analysis of the landscape of health research for poverty-related and neglected infectious diseases (PRNIDs) and national funding commitments in sub-Saharan Africa. The report included desk based reviews of health research publications (globally), and a fieldwork exercise in 46 sub-Saharan African countries that was sub-contracted to Baird’s CMC. Discussions on how to build synergies with other relevant initiatives and activities were held with other bodies and funders such as ESSENCE, COHRED and DSW. The results of the projects were presented during the 7th EDCTP Forum in Berlin, Germany and RAND, BAIRD’s CMC and EDCTP jointly published a high level report on the outcomes of the project. This report was distributed during the 7th EDCTP Forum and was made publically available on the website of the three organisations that authored the report.
4.1.3.4 Bibliometrics
As part of the mapping project this component was contracted in month 13 to Thomson Reuters Evidence, a firm specialised in bibliometric citation analysis. The objective of the study was to quantify research outputs of European and African researchers in the above mentioned research areas, identify leading institutions and researchers in these fields, and describe collaboration patterns at a country and institutional level. The bibliometric analysis and other mapping activities contribute to informing the scope and strategy for EDCTP2 and to enable future analysis to measure impact of the programme. The project also strengthened EDCTP’s future analysis of publications arising from EDCTP-funded research. A final report was submitted i and results were also presented at the Seventh EDCTP Forum. A peer-reviewed article summarising the findings of this research was submitted to PLOS Neglected Tropical Diseases on 17 November 2014 and is still under review (see Template 1A). Furthermore, Thomson Reuters Evidence performed a supplementary analysis on the newest EU Member States and their collaborations with other European countries based on research outputs. The analysis quantified research collaboration between two groupings of European countries: EU-12 plus Croatia and the EU-15 plus Norway and Switzerland, between 2003 and 2011. The report was completed.
4.1.3.5 Mapping of research programmes and relevant research cooperation activities in the newest EU member States
The country profiles of Finland and EU-12 plus Croatia were also finalised and included in a separate report titled “Full report of European EDCTP partner countries’ national programmes and activities: Newer European Union Member States and Finland”
4.1.3.6 Preparation of a new template for reporting of EU EDCTP partner countries’ funding and activities for EDCTP2
A template was developed for Participating States to report on national activities (‘PSIAs’) to be included in the EDCTP annual work plan. This template formed the basis to develop the online portal in the grants management system CC Tracker for General Assembly (GA) members to report on activities included in their national annual work plans.
4.1.3.7 Profiling of EDCTP partner countries and other activities to foster cooperation and integration of EDCTP partner countries activities and programmes
To accomplish this activity the following actions were implemented:
• Dedicated mailings and targeted telephone conferences with current EDCTP partner countries that were less active in 2013 (i.e. Ireland, Greece, Luxembourg, Portugal)
• Invitations sent to representatives from 12 newly joined European countries to attend a webinar on EDCTP in 2013
• Invitations sent to partner countries and prospective partner countries to attend EDCTP stakeholder meetings (attendance from Lithuania, Croatia, Latvia) and Seventh EDCTP Forum in 2013
• Consultation with EDCTP partner countries regarding research priorities throughout 2013 for completion of Participating States work plans
• Identification of MS funding to product development partnerships (PDPs) and related activities that could be included in the EDCTP-II work plan in 2013
• Participation in networking events to promote EDCTP to representatives of EU-13 (e.g. booth at Open Info Day on Horizon 2020) in 2014
• Compilation of dedicated mailings and targeted telephone conferences with EDCTP Participating States that were less active in 2014 (i.e. Ireland, Greece, Luxembourg). All the EDCTP1 European partner countries, except for Greece and Belgium, confirmed their participation in EDCTP2 and had indicated their in-kind and/or cash commitments
• Face to face meetings in the Hague with Ireland and the UK to provide an overview of the new funding mechanisms under EDCTP2 and to discuss the requirements for the annual country specific work plans in order to better align the research objectives of the national institutions in 2014
• Invitations to partner countries and prospective partner countries to attend EDCTP stakeholder meetings (attendance from Lithuania, Croatia, Latvia) and Seventh EDCTP Forum in 2014
• Consultation with EDCTP partner countries regarding research priorities throughout 2014 for completion of Participating States (PSs) annual work plans for 2014 and 2015
• Identification of PS funding to product development partnerships (PDPs) and related activities that could be included in the EDCTP2 work plan
• Participation in networking events to promote EDCTP to representatives of EU-13
o Submission of an abstract of EDCTP2 programme presented at the 11th Annual Conference of the Baltic Network Against Life-threatening Viral Infections in Vilnius, Lithuania, on 24-27 April 2014
o Attendance at information day on the EDCTP2 programme in Prague, jointly organised by the Czech Ministry of Education, Youth and Sports and the Technology Centre of the Academy of Sciences of the Czech Republic (ASCR) on 26 March 2014
• Contact with PS to raise funds for the Seventh EDCTP Forum
• Regular contact with PSs to compile national work plans in 2014.
4.1.3.8 Identification of future research priorities
Four Scientific Advisory Committee meetings and six stakeholder meetings took place and discussed EDCTP future research priorities that informed updating of EDCTP Strategic Business Plan and preparation of annual work plans. The Secretariat played an active role in these meetings and prepared the necessary background documents and briefing material.
4.1.3.9 EDCTP-EFPIA Fellowship Scheme
Following meetings with WHO-TDR in September 2013, EDCTP and WHO-TDR on 27 March 2014 signed a Letter of Collaboration to jointly implement a fellowship scheme for scientists and clinical staff from low-and middle-income countries (LMICs). This partnership will strongly enhance the work which each organization has in common and thereby strengthen research capacity in developing countries. A larger number of scientists and clinical staff will be trained, resulting in an increased impact on research and development capacity in LMICs. The partnership will ensure synergies between the different parties involved, and will facilitate common communication with researchers, pharmaceutical companies and home institutions. This fellowship scheme will be launched annually and the first Call for proposals was launched on 31 October 2014. In total 20 organisations (pharmaceutical companies and product development partnerships (PDPs) participated to this first call and agreed to host one or more fellows for a duration of up to two years.
4.1.3.10 Scholarships for MSc programme in vaccinology in Siena, Italy
Six scientists among fifteen training awardees from sub-Saharan Africa involved in EDCTP-funded vaccine development projects successfully defended their thesis at the University of Siena on 17 November 2014 and were presented with the Master certificate in Vaccinology and Pharmaceutical Clinical Development. In 2015, the 4th Master Course in vaccinology will commence and six candidates from sub-Saharan Africa have been shortlisted. The final selection of candidates will be made by the university in February 2015. The objective of the Master’s programme is to build capacity in vaccinology and vaccine development in developing countries. The Master’s programme is offered by the University of Siena Medical School, Novartis Vaccines and Diagnostics, Novartis Vaccines Institute for Global Health (NVGH), and ADITEC (Advanced Immunization Technologies).
4.1.3.11 Collaboration with the Bill & Melinda Gates Foundation (BMGF)
In 2013 EDCTP Secretariat discussed with BMGF the plans for jointly funding a Randomized Clinical Trial of the Effects of Progestin-Only Contraception and the Copper Intrauterine Device (IUD) on the Risk of HIV Acquisition in Young Women (Echo Trial). A follow-up meeting took place at the EDCTP HIV stakeholder meeting on 3 September 2013. In January 2014, EDCTP was approached by the Bill and Melinda Gates Foundation and the National Institutes of Health (NIH) to enquire about EDCTP’s potential interest to participate in the joint funding of the Global TB Alliance’s STAND trial (NC-006) (Shortening Treatment by Advancing Novel Drugs). This is a multi-centre clinical trial to evaluate the efficacy, safety and tolerability of the combination of moxifloxacin plus PA-824 plus pyrazinamide (the M-Pa-Z regimen). Apart from aiming to shorten treatment with drug-sensitive patients, the M-Pa-Z regimen also offers the promise of improved cure rates for MDR-TB patients. The potential funders group, which included members of the Gates Foundation, NIH and EDCTP held monthly teleconferences throughout 2014 about the progress of securing funding for the STAND trial. It is expected that the trial will be launched in 2015.
4.1.3.12 CASPA Initiative
In 2013, EDCTP facilitated the organisation of a breakfast meeting together with PATH Malaria Vaccine Initiative (MVI), Medicines for Malaria Venture (MMV) and GlaxoSmithKline Vaccines for potential donors of the CASPA Initiative. EDCTP together with the EDCTP Participating States, the European Commission, the European Federation of Pharmaceutical Industries and Associations, GSK and Sanofi also organised a lunch meeting during the Seventh EDCTP Forum to explore opportunities to develop an effective and sustainable pharmacovigilance platform in sub-Saharan Africa. The overall objective of this meeting was to bring together interested stakeholders and to define next steps for the creation of such platform.
4.1.3.13 Global TB Vaccine Partnership (GTBVP)
In 2013, EDCTP started discussion with the Global TB vaccine Partnership to consider broader EU Member States participation in the GTBVP, which would strengthen EU leadership in TB vaccine development. During 2014, EDCTP attended multiple telephone conference and face to face meetings of the working group and facilitated the organisation of a satellite meeting by the working group during the Seventh EDCTP forum in Berlin. The GTBVP will be looking into the best incorporation options for an eventual GTBVP legal entity.
4.1.3.14 Calouste Gulbenkian Foundation
During the Seventh EDCTP Forum EDCTP and representatives of the Gulbenkian Programme Partnerships for Development decided to collaborate to support sub-Saharan African countries in developing a robust ethical and regulatory framework for conducting clinical trials. The Gulbenkian Foundation will provide cofunding to support successful applications from Portuguese speaking African countries to Calls for Proposals launched by EDCTP to strengthen ethics and regulatory capacities in sub-Saharan Africa. This collaboration was formalised during collaboration signing ceremony in Lisbon on 9 March 2014.
4.1.3.15 Development Agencies
To increase the impact of EDCTP2 effective cooperation with relevant EU initiatives, including its development assistance the EDCTP GA decided to reconvene a Development Cooperation working group and this group held several telephone conferences. On 13 February 2015 a meeting will be scheduled in The Hague to provide an opportunity for an informal information exchange between EDCTP and representatives from some of the key European development cooperation agencies to explore pragmatic strategies and ways to collaborate. The meeting is expected to result in the identification and prioritisation of areas on which to jointly fund or coordinate the funding of activities and an agreed way forward for better engagement with one another. Feedback and recommendations will also be sought on the plans and preparations for a possible follow-on meeting with a larger group of development cooperation agencies and other relevant stakeholders, to be hosted by DG DEVCO in Brussels in 2015.
4.1.3.16 Cooperation with other agencies
In addition to activities mentioned above EDCTP Secretariat participated in monthly telephone conferences with AREAS in order to be updated on AERAS development pipeline and to inform then about the new funding mechanisms under EDCTP2. It also participated in a telephone conference and held face to face meeting with representative of Bioventures for Global Health.
4.1.3.17 Joint Activities with third-parties
The legislative proposal for EDCTP2 provided the opportunity to “launch joint calls with third countries or their scientific and technological organisations and agencies, with international organisations or with other third parties, in particular non-governmental organisations”. Joint Activities with third-parties will provide an opportunity for EDCTP to partner with other major funders and to support an activity that is strategically important to EDCTP but too large to be covered in full by EDCTP alone. EDCTP Secretariat updated the strategy and rules of engagement with third-parties, including transparent engagement rules and an outline of the different funding modalities in EDCTP2 to increase private sector collaborations and potential joint calls. This document guides the participation of third-parties in EDCTP2.
4.1.3.18 Support for continuation of EDCTP funded regional Networks of Excellence
The four EDCTP funded regional NoEs are Central Africa Network for TB, AIDS and malaria (CANTAM), East African Consortium for Clinical Research (EACCR), Trials of Excellence for Southern Africa (TESA) and West African Network for TB, AIDS and malaria (WANETAM). As part of CSA grant, these NoEs received support to upgrade capacity under the following categories: (1) information and computer technology infrastructure upgrade for improving communication within and across the networks; (2) short-term training activities, uniquely prioritised by each individual network; (3) development of laboratories selected by the NoEs in preparation for future internationally recognised accreditation (coordinated directly by EDCTP Secretariat) and (4) financial and project management as a mandatory requirement for all NoEs. The fourth category was a universal capacity gap identified by and coordinated directly by the EDCTP Secretariat.
4.1.3.19 Information and computer technology infrastructure upgrade
All four NoEs benefited with improvement of ICT facilities for use within and across the networks. These improvements included facilities like VoIP (Voice over Internet Protocol) and NAS (Network Attached Storage) system for backups and file sharing, installation of video conference systems, American Power Conversion (APC) smart central uninterruptible power supply (UPS), new computers, printers and appropriate software. Besides potential reduction for future travel costs, such improvements are also aimed at enabling NoE to prepare for activities like E-learning platforms, biobanking and database management.
4.1.3.20 Short term trainings
In TESA three short-term training courses on tuberculosis and eight crosscutting issues were conducted. The Spoligotyping and mycobacteria interspersed repetitive unit (MIRU) Diagnostic Techniques workshop prepared participants for the analysis and typing of TB-MDR/XDRTB genome for multisite clinical trials and biomarker studies of tuberculosis. In addition the clinical pharmacokinetic-pharmacodynamic (PK/PD) research training resulted in an immediate output where attendees could prepare a protocol outline for their own PK/PD clinical research studies. 107 staff were trained in cross cutting courses that included:
• Project management for clinical staff
• Good Clinical Practice (GCP) training of trainers
• Good Clinical and Laboratory Practice (GCLP) training of trainers
• Full International Air Transport Association (AITA) training in handling dangerous research products
• Refresher IATA training
• Intermediate biostatistics
• Scientific writing
• Clinical PK/PD for HIV/TB/malaria.
In EACCR cross-sectional workshops trained 75 staff in courses that included:
• TB epidemiology and microbiology
• Integrated management of TB-HIV infection
• HIV guidance and counselling
• GCLP training
• Research management
• TB/HIV co-infection management
• Mentoring and cross-site clinical trials monitoring.
EACCR also successfully implemented a reciprocal monitoring scheme, an innovative in-house strategic quality management tool for the EACCR clinical trials. The scheme led to the mentorship of 13 new monitors by 12 experience regional monitors and also managed to attract and facilitate participation of 1 new Rwandese partner. TB techniques training via mentorship laboratory attachment was provided to several laboratory technologists. The areas covered in the training 24 staff were:
• Epidemiology
• GCLP and a visit to the Institute of Endemic Diseases clinical trial site in Sudan
• Qualitative culture training
• ISO15189:2007 training
HIV-related mentorship training was provided to 8 HIV/AIDS node members. The members were trained on use of Nvivo 8 software to analyse, interpret and report qualitative research data. Other courses included ethics.
In WANETAM HIV and Tuberculosis workshops trained 32 staff. The disease specific training included:
• Mass spectrophotometry
• Drug sensitivity testing for first and second line anti-TB drugs
• Molecular phylogeny
• Advanced molecular phylogeny
• HIV resistance, quality assurance and data management
• Microbiology
• University diploma in retrovirology
• ARV resistance testing.
Crossing cutting training for 65 staff included the following topics:
• Applied Elispot and flow cytometry
• International monitoring and evaluation
• Monitoring and evaluation
• Project development and grant writing
• Clinical trials short course
• Project costs management
• Laboratory accreditation preparation in three parts: (i) risk and chemical dangers, (ii) knowledge management of non-conformities, (iii) mastery of measurement of process
• MS project planning
• Quality control
• Advanced excel stock management
• Project Management Professional
• Procurement and purchasing
• Monitoring and evaluation training to enhance the knowledge of a few WANETAM members as internal quality control and network evaluation resource persons. Database creation and management using Access computer programme
• STATA training to strengthen capacity for statistical analysis of data collected within the scientist network.
In CANTAM disease specific training for 61 staff contained:
• TB culture, drug sensitivity testing, quality control and bio-safety
• Genotyping and mutational methods
• TB clinical trials
• Standardisation of ELISA analyses
• In vitro culture of plasmodium falciparum and drug sensitivity testing
• Standardisation of PCR based parasite genotyping
• Drug resistance and viral load determination for mother to child transmission.
Cross-cutting training involving 90 staff included the following topics:
• Workshop for ethics committees and investigators
• Clinical data management in TB and malaria
• Biostatistics
• Online and on-site epidemiology
• Neglected Infectious Diseases (NIDs) molecular detection
• GCP.
4.1.3.21 Financial management training
Through EDCTP-Plus 34 project managers and investigators were trained in finance and project management. Of these 15 were trained in Dakar between 26 and 27 June 2013 while 19 were trained in Johannesburg between 16 and 17 July 2013. The objective of these workshops was to provide participants with the required knowledge and project management skills necessary for them to improve project management at their respective institutions. Topics covered included:
• Auditing
• Budgeting preparation and negotiation
• Cash management
• Purpose and objective of internal controls
• Fraud and Error
• Financial statements
• EDCTP financial guidelines:
o Accounting policies
o EDCTP budgeting rules
o No cost extensions
o Cofounding
o Disbursement procedures
o Foreign exchange risk
o Accounting for overheads
o Eligible and ineligible costs
• Bribery Act and Anti-Corruption
• Project Management in EDCTP projects
• Project Management - Key terms & Process
• Project management tools and techniques
• Creating a Clinical Trials Project Plan
• Managing the Plan
• Reporting progress
• Project risk management.
Post-training evaluation shows that attendees found the workshop useful; and they are convinced that the knowledge they have acquired will help them to strengthen project management at their different institutions.
4.1.3.22 Laboratory upgrades towards accreditation
Twenty four laboratories (six per NoE), were selected for Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA). These laboratories are located in 18 sub-Saharan African countries: Burkina Faso, Cameroon, Congo, Ethiopia, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, Senegal, South Africa, Sudan, Tanzania, The Gambia, Uganda, Zambia and Zimbabwe. Initial assessment of all 24 laboratories was completed in 2013 by LQT. Table 2 shows the number of laboratories under each rating within each NoE. Through a selective tender process, the African Society of Laboratory Medicine (ASLM) and Quintiles were identified as suitable firms for mentoring the selected laboratories. ASLM was allocated 16 laboratories with a star rating of zero to 2 based on SLIPTA scale, while Quintiles was allocated the remaining 8 laboratories with stars rating 3 and above, based on SLIPTA scale.
The laboratories are in the process of implementing the ongoing corrective actions and closing identified gaps.
By the end of 2014, three out of 24 laboratories namely MRC-Gambia, MRC-UVRI and University Cheikh Anta DIOP (LBV) had applied for accreditation.
The overview of laboratories by end of 2014 is summarised in the table below.
4.1.3.23 Support to Pan African Clinical Trials Registry (PACTR)
The CSA grant supported expansion of the registry remit to accept all clinical trials (I-IV) including pharmacodynamics and pharmacokinetic studies; supporting completion of registry upgrading activities which included debugging of the current database, portal maintenance and portal optimisation to comply with the new minimum standards for the WHO Trial Registration Data Set (TRDS); supporting progression to Phase IV development developments. Phase IV developments of the registry which include development of partner registry capabilities, supporting improvement of search functionality, linking of publications by trialists and supporting further development of the registry’s data management including user friendly search functions capacity that permit users to save search results as well as the creation of discussion forums.
The deliverables that have been achieved by PACTR as of end of 2014 were as follows:
• 24 trial information transfers have been submitted to WHO International Clinical Trials Search Platform in order to maintain WHO status
• 20 working group meetings have been held. These consultative technical meetings are through teleconferences and involve advisors from Liverpool School of Tropical Medicine, Australian national clinical trials registry, WHO headquarters and Africa regional office, Africa Vaccine Regulators Forum (AVAREF), South African national clinical trials registry and the Medical Research Council of South Africa. These technical meetings have shaped and delivered a 5-10 year strategic business plan for PACTR that includes a sustainability strategy.
• 7 lectures have been conducted to actively promote PACTR and clinical trial registration within the African region
• 3 publications have been developed and published in reputable peer reviewed journals
• PACTR launched a call to Regional Regulatory Authorities to partner with them. Two potential partners have been selected and are in the final stages of receiving approval from WHO for official partnerships. The pilot testing of the process of partnering is enabling the possibility of partnering with many other national registries. PACTR has facilitated a face-to-face training and engagement with the Ugandan National Regulatory Authority to discuss the structure, function and processes of clinical trial registration and partnering
• The Geographic Information Systems (GIS) component was launched and is continually updated as trials are registered to reflect a real-time picture of the registry’s content. The website was revamped so that the look and feel of the site is more contemporary and accessible.
• Phase IV database development was completed and included streamlining administrative functions, thereby improving search functions and ensuring that the database and related registry web-pages are improved.
There has been an exponential growth in the number of trial registrations in PACTR (Figure 1).
4.1.3. 24 Implementation of a new, improved grants management system with updated grants management policies, procedures and processes in preparation for the anticipated expanded scope and scale of EDCTP2.
The EDCTP Code of Conduct and Declaration of Interests Policy was drafted and approved by the GA. The policy applies to reviewers, members of EDCTP governance bodies (i.e. GA and SAC), staff members and contractors. Declaration of interest forms have been revised in line with the policy. Revision and update of application forms for Integrated Projects and Fellowships were accomplished. The forms were revised to ensure compliance with the H2020 rules for participation. A new final report form for EDCTP’s Integrated Projects and Member States Initiated Projects was released. The new format has facilitated collection of outputs and indicators on EDCTP achievements. The reviewer assessment form for final reports was updated in accordance with the new report format. Revision of EDCTP Standard Operating Procedures (SOPs) was completed. The SOPs reflect the new working arrangements in line with the Rules for Participation of Horizon 2020 and the introduction of an electronic grants management.
An online system for recruitment of expert reviewers will be finalized and introduced on the new EDCTP website. The preliminary system will consist of a hyperlink on the EDCTP website which opens a registration form that will allow potential expert reviewers to register themselves as potential experts. An electronic grants management system (CC Tracker) is operational. An expanded database of reviewers will be an integrated module of the electronic grants management system.
4.1.3.25 Evaluation of EDCTP1 programme
EDCTP1 external evaluation was undertaken and completed by the firm Technopolis BV. Amsterdam, the Netherlands.
4.1.3.26 Strengthening of EDCTP site evaluation and audit procedures by adoption and piloting of a common financial audit framework developed in partnership with other funding agencies
During the CSA period EDCTP has been working with members of the International Financial Governance Consortium (IFGC) to develop common approach to dealing with some of the financial management capacity challenges of conducting clinical trials in sub-Saharan Africa. The formed International Financial Governance Consortium has worked together to develop a Financial Management Assessment Tool (FMAT) that will be used to assess the financial management capacity of new sites. Two reports have been published in two newsletters and shared with third parties.
4.1.3.27 Financial audits
The following sites were audited by PWC Netherlands in 2013:
• Makerere University
• Uganda Virus Research Institute (UVRI)
• Centre Hospitalier Universitaire Aristide Le Dantec
• Academisch Medisch Centrum (AMC)
• Université Cheikh Anta Diop (UCAD)
• University of Zimbabwe Clinical Research Centre (UZCRC)
These sites were selected based on the following selection criteria:
• Actual expenditure more than €250,000
• End date of the project is not within the next 12 months
• Projects with many Grant Finance Officer observations in previous financial reports
• Sites with more than one EDCTP funded project
• Previous unfavourable site visit reports
• Sites with high staff turnover in the finance department.
In addition to the external audits by PWC, three site visits were carried out by the Secretariat to review the financial management systems and procedures. These included a review of the following:
• Bank reconciliation statements to ensure that bank reconciliations are performed and reviewed on a regular basis
• Financial transaction documents
• Fixed asset registers
• Payroll reports
• Extent of compliance with EDCTP financial guidelines
• Overall financial and internal control systems.
4.1.3.28 Development of a new, improved integrated information management system
The following objectives have been achieved in this area:
• Purchase of essential hardware to ensure the security, back up and long term storage of EDCTP systems and data
• Data cleaning and data entry into the new project database. Design and finalisation of database fields for collection of key project data
• Fixed asset register module was purchased and implemented. This has improved the system of custodial control over assets. These include computers, office equipment and other assets
• Sage HR module was purchased and implemented. This has improved the management of HR records
• Development of an operational information system that integrates the accounting and project databases into a single system with full access and functionality for EDCTP staff in the Africa and Europe offices
• Implementation of an electronic grants management system.
4.1.3.29 EDCTP2 work plan
The first draft of the EDCTP work plan, which describes the activities to be implemented during the first two years (2014-2015) of the new programme, was written in November 2013 and presented to the EDCTP Interim SAC and the EDCTP GA in December 2013. After several revisions the work plan was approved by the EC in December 2014 and the GA in January 2015.
Potential Impact:
4.1.4.1 High level meeting
The high-level conference on the second EDCTP programme which included discussions on stakeholders’ needs, opportunities and expectations in EDCTP2 increased knowledge about the programme and stimulated participation of Africa countries in the second phase of the programme. The 2014 member states work plans show substantial in-kind and cash contributions from both African and European member states. The report of this conference is published on EDCTP website.
4.1.4.2 Collaboration with private sector and product development partners
Numerous meetings were conducted to enforce EDCTP collaboration with the private sector and Product Development Partnerships. This has brought on board pharmaceutical companies and other third-party organisations including Product Development Partnerships (PDPs), Pharmaceutical companies, non-EDCTP partner countries, other funding agencies, and like-minded organisations to potentially partner EDCTP in funding the second programme. Publications of meeting reports and key invents like signing of memorandum of understanding were published on the EDCTP website.
4.1.4.3 Developing integration and funding strategies: mapping of and cooperation between national programmes
Mapping European and African countries’ national programmes and activities within the anticipated scope of EDCTP2 to determine research priorities for malaria, HIV, tuberculosis, NIDs and health services optimisation research as well as to establish baseline data on research activities and funding for research of European participating States and African Partner Countries potentially increased knowledge among EDCTP2 member states and its partners. A mapping report was produced and is downloadable from the EDCTP website.
4.1.4.4 Bibliometrics
The bibliometric analysis and other mapping activities potentially contributed to increased knowledge about the scope and strategy for EDCTP2 and enabled future analysis to measure impact of the programme. The project also strengthened EDCTP’s future analysis of publications arising from EDCTP-funded research. Results have been accepted for publication in an international journal.
4.1.4.5 EDCTP-EFPIA Fellowship Scheme and Scholarships for MSc programme in vaccinology in Siena, Italy
Implementing these training programmes has increased collaboration between pharmaceutical companies, product development partnerships (PDPs), WHO-TDR and EDCTP. This will potentially increase the flow of third party funding to EDCTP2 activities.
4.1.4.6 Support for continuation of EDCTP funded regional Networks of Excellence
Support to the four EDCTP funded regional NoEs has improved scientific, information and computer technology infrastructure within the networks. These activities potentially added to the economic activities in the countries involved as most of the materials were locally purchased. Several trainings also provided employment to the trainers and their institutions.
4.1.4.7 Support to Pan African Clinical Trials Registry (PACTR)
The expansion of the functions of PACTR has resulted in increased capacity to record and present clinical trials in Africa. This is an important resource to scientists, regulators, policy makers and other EDCTP partners. PACTR presents a pool of knowledge to such beneficiaries including meta-analysis of collected studies for generating evidence for policy.
4.1.4.8 EDCTP2 work plan
The EDCTP work plan has provided a framework and guidance for implementing EDCTP2. Member states’ activities and contributions are presented in the plan. This potentially contributes to synergy of member states’ efforts and better understanding of the partners to the programme. The work plan was approved by the EC in December 2014 and the GA in January 2015.
List of Websites:
www.edctp.org
