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Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS)

Periodic Reporting for period 1 - STARS (Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS))

Reporting period: 2019-01-01 to 2020-06-30

Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients.
STARS has the objective and the potential to complement, coordinate and harmonize regulatory efforts among Member States and at European level to support academic health research for the benefit of patients. The aim is to reach academic researchers very early in the planning of relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.
The STARS consortium is represented through 20 national competent authorities (NCA) and EMA, and is advised and supported by academic and industry representatives, and associations with relevant experience.
The working programme of STARS is divided into six work packages (WP) and the following work has been performed in the WPs:
WP1 implemented the coordination and management of the project, ensuring that the action is implemented properly. WP1 performed continuous monitoring of the work by the partners of the whole consortium and all WPs. The project management office ensured that the administrative procedures and expenditures were done according to the description of action (DoA) and supported all the tasks, meetings, and pilots as outlined in the work packages. WP1 developed a data management plan that involved all aspects of data management of this consortium, especially considering the ORDP policy.
WP2 established and published the Comprehensive Inventory (CI) of existing support activities for regulatory Scientific Advice and Protocol Assistance in Europe. For this purpose, WP2 developed a survey to obtain the required information from academic researchers, academic clinical research centers and funding organizations. The work package was responsible for survey conduct, data collection and data analysis and development of the CI based on the information obtained via the surveys. The CI is now published on the STARS website. Its purpose is to assist European academic drug developers in finding regulatory support. The inventory lists various support services provided by national competent authorities, public actors and private entities.
WP3 has collected and analyzed the existing Scientific Advice activities given by the national competent authorities requested by academic groups. For this, WP3 developed a questionnaire on Scientific Advice activities and addressed the survey to the relevant Scientific Advice offices of each NCA and to EMA. The received information will complement those collected by the WP2 surveys, not only by adding entries to the comprehensive inventory but by helping to draft the common strategy, which shall be the future roadmap for enhanced support und communication between the academic applicant and the authorities.
Based on the survey data obtained in WP2, WP4 has identified a best practice example for a training programme in regulatory support. This best practice example will be transferred to other member states (Pilot I). Moreover, WP4 has identified a gap of significant relevance, a need that is not addressed by any existing support activity. Based on this information, WP4 developed a concept for a novel support activity (Pilot II). The implementation of both pilots will be the focus of the upcoming project phase.
The key-objective of WP5 was to analyze the existing gaps in regulatory science in academia based on the outcomes of the previous work packages, to assess the need for and possibly propose additional mechanisms to sustainably support academic groups in regulatory science. WP5 has finalized a manuscript for a White Paper, which gives an overview of the current landscape in the Member States framed in lessons learned and gaps identified.
WP6 ensured adequate dissemination and communication of the intermediate and final outcomes of the project to a larger audience via suitable and efficient communication tools, e.g. by launching the STARS website (https://www.csa-stars.eu/). WP6 organized the first of two European Stakeholder Workshops and one Global Regulatory Science Conference. The first European Stakeholder Workshop was postponed due to the Covid-19 pandemic. It will take place in a virtual format and will bring together the relevant stakeholders like academic partners, funding bodies, regulatory, patient representatives and industry representatives. The topic of the workshop is “Towards Improved Strategy Regulatory Support for Academia” and the results will contribute to the Common Strategy of STARS.
The project will improve regulatory education, but focus also on all other kinds of support activities suitable to enhance success and outcome during regulatory Scientific Advice procedures. STARS will coordinate efforts between the NCAs and European partners, relevant initiatives and stakeholders, and the academic research community on the national and European level. The project will consequently address both aims: improving general knowledge on regulatory issues in the academic world, and strengthening support for successful outcomes during regulatory Scientific Advice with direct regulatory impact of academic driven research. Given that many academic driven research projects focus on development and validation of new methods, improving regulatory support for such innovations has a great potential to enhance benefit for patients (for example by supporting validation/qualification of innovative clinical endpoints such as surrogate outcomes for response or predicting patient profiles for safety).