Strengthening Ethics and Responsible conduct of Clinical Trials in East and Sub-Saharan Africa

Project Information

SERCEA

Grant agreement ID: 101103307

DOI

10.3030/101103307

EC signature date 17 May 2023

Start date 1 July 2023

End date 30 June 2026

Funded under

• Health

Total cost

€ 599 000,00

EU contribution

€ 599 000,00

Coordinated by

UNIVERSITEIT MAASTRICHT
Netherlands

Periodic Reporting for period 1 - SERCEA (Strengthening Ethics and Responsible conduct of Clinical Trials in East and Sub-Saharan Africa)

Reporting period: 2023-07-01 to 2024-12-31

Summary of the context and overall objectives of the project

The increased number of clinical trials taking place in Africa as well as the complexity of clinical trials designs require that countries have the regulatory capacity to review, monitor and utilize data generated from the research. Research Ethics Committees/Institutional Review Boards, Institutional Animal Care and Use Committees and National Regulatory Agencies (NRAs) are required to be abreast with the evolving landscape thus require continuous capacity building as well as have platforms to share Clinical Trials information with both the public and private sector. The 11th Annual National Research Ethics Conference held in 2021 in Uganda highlighted challenges in the low and middle income countries for research ethics and open science specifically, the lack of infrastructure for open data sharing and fair data management. This project focuses on strengthening ethics and responsible conduct of Clinical Trials in East and Sub-Saharan Africa through the establishment of a research ethics and integrity framework, open data access framework for Clinical Trials, E-learning platform for the Good Research Regulatory Research Practice Course and establishing Research Ethics Committees in National Regional Hospitals. Having a robust regulatory system, encompassing research integrity and open science will ensure that Clinical Trials are conducted to the highest ethical standards and in compliance with existing polices and laws, hence protection of safety, rights and welfare of the individual participants, community, researcher and sponsors.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

WP 1:Establish a research integrity code of conduct
The survey study 1 received ethics approval in all 4 partner countries. There was extensive work required before we could reach this milestone, namely coordination with each country on their EC specific processes and timelines, legal requirements that needed to be met before email addresses of the survey target groups could be compiled and shared, logistical preparation for sending out large number of survey invitations to the target groups in each country to name a few. The benchmarking visit to the University of Cape Town's Research Integrity office gave partners UNCST and KUHeS insight into the set up of such an office. The knowledge gained will be use to guide their own research integrity office set up within their organisations.
WP 2:Establishment of an Open data Access platform for Clinical Trials
COSTECH conducted a workshop that involved stakeholders from Research and Development (R&D) institutions and higher learning institutions across Tanzania. The workshop aimed at gathering insights and requirements to ensure the open data access platform aligns with the needs of researchers, institutions, and policymakers. During the workshop, the stakeholders identified key functionalities, user needs, and technical specifications for the open-access data platform.
The Open Data Access Platform for clinical research will serve as a repository where researchers can upload and access clinical datasets, reports, and publications. The platform will be operated by enabling the secure sharing, access, and management of research data, publications, and reports. The open data access platform would operate as follows:
1. Data Submission: Researchers will upload clinical datasets, reports, and publications after ensuring compliance with ethical and regulatory guidelines.
2. Data Governance: Consortium members/partners will oversee data quality, privacy, and security, ensuring adherence to policies like GDPR or HIPAA.
3. Search & Retrieval: Users can explore datasets and reports using metadata-driven search and filtering tools.
4. Interoperability & APIs: The platform provides APIs for integration with other research databases, allowing seamless data exchange.
5. Collaboration & Feedback: Researchers can collaborate, cite datasets, and provide feedback, enhancing data reuse and transparency
Main Achievements in WP 2:
• Strong Stakeholder Collaboration: Built consensus among R&D institutions and higher learning institutions, fostering ownership and commitment to the platform.
• Kickoff of Platform Development: Transitioned from the planning phase to the implementation phase with a clear roadmap.
• Foundation for Open Data Sharing: Laid the groundwork for a platform that will enhance access to clinical research data, promoting transparency, collaboration, and innovation among collaborating countries.

WP 3: Develop and implement an E-learning platform for Good Research Regulatory Practice (GRRP)

The deployment of the eLearning platform at https://elearning.costech.or.tz/ marks a significant milestone in providing digital learning resources. The main activities performed, and achievements include platform development where initial installation and setup of the eLearning platform, ensuring it is functional and accessible online. Main achievement includes initial platform's deployment provides a foundation for future online learning initiatives.
Ongoing Activities:
• Customization of the platform to meet specific user and institutional requirements. Further the team has started to develop online contents of the GRPP course to generate high-quality online learning materials to support various educational programs and addresses the needs of target audiences.

WP 4:Capacity building and establishment of Research Ethics Committees in National Regional Referral Hospitals
The UNCST organized a meeting with hospital directors and administrators on the 8th December 2023 to emphasize their role in research governance and the need for establishing accredited Research Ethics Committees (REC) in Regional Referral Hospitals. This helped secure commitment from three hospitals to establish RECs. These are Kawempe National Referral Hospital in central Uganda, Soroti Regional Referral Hospital in eastern Uganda and Fortportal Regional Referral Hospital in Southwestern Uganda.
Following the meeting with the Hospital Directors, UNCST has started the accreditation process for establishment of Research Ethics Committees (RECs) at Kawempe National Referral Hospital in central Uganda, Soroti Regional Referral Hospital in eastern Uganda.

WP 5:Coordination and Support
A dedicated project website and logo has been set up at https://www.serceaproject.org/. Two Project in person meetings were held in Kampala Uganda on 25 July 2023 and in Nairobi Kenya on 1-2 July 2024. Data management, Dissemination and Exploitation Plans have been created and shared with partners.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The Research Integrity Code of Conduct for the four partner countries will serve to fill a gap in the region on research integrity guidance. It will help bring African context to the table on research integrity and what the region needs in order to uphold research quality. The eLearning platform will serve as a centralized hub for online education and training resources. When completed, the platform will extend learning opportunities to underserved or remote communities supporting inclusivity and equity in education. Online training modules will help build skills and competencies across diverse sectors, contributing to national development goal. In addition the platform will create a space for continuous learning. The Open data access platform for Clinical Trials will enable sharing of research findings enhancing the impact, transparency and accountability of research activities and findings.