The work programme of STARS was divided into six distinct work packages (WP).
WP1 was responsible coordination and management, monitoring of deliverables and milestones, processing of administrative procedures, organisation of meetings, and support of all project tasks. WP1 developed a data management plan that involved all aspects related to this consortium, especially considering the ORDP policy.
WP2 published the Comprehensive Inventory (CI) to assist European academic drug developers in finding support on regulatory affairs. This information has never been complied in a single place. WP2 developed a survey to obtain information on existing support activities and their usage. The surveys targeted academic clinical centres and researchers, funding organisations, and NCAs. The data collected provided the basis for further activities in STARS.
WP3 analysed the scientific advice activities of academic groups. The data were used to develop concepts for the Core and Comprehensive Curriculum, which are considered as a superordinate recommendation for an EU-harmonized training. WP3 drafted the Common Strategy, the STARS road map for the implementation of support activities and training programmes. The document was launched at the STARS global conference. It is published on the STARS website and pro-actively disseminated to relevant stakeholders. WP3 developed a concept for a pre-grant regulatory scientific advice (PGRSA) as part of the Common Strategy. The idea of the PGRSA concept is to provide early regulatory scientific advice for grant applications to encourage support for successful outcomes of research projects.
In order to demonstrate that selected support activities and elements work efficiently, WP4 has performed three pilots. Pilot I was a transfer of a best-practice example to other member states. To this end, WP4 designed a 4-day training course for clinical researcher. The course took place on 23-26 February 2021. The course slides were published on the STARS webpage.
For Pilot II, WP4 identified a gap which requires the establishment of a new support activity. The survey data revealed a need for tools to improve the communication between regulators and academia. The new support activity was a one-stop-shop for academic and clinical researchers. The Pilot II run from 1-30 September 2021 as an online communication platform for Spanish academia. It offered a low-threshold way for clinical researchers to get information and feedback to regulatory questions and to improve future scientific advice.
For Pilot III, WP4 collaborated with relevant Spanish academic post-graduate nets, hospitals and non-profit institutions to implement the Comprehensive Curriculum. It was available from 16 February - 16 March 2022. The online training is published on the STARS website. Overall, the three pilots were rated as very supportive, helpful and user-friendly. The majority of users considered that the pilots met their needs, even though they have stated that more detailed and precise information on product development, non-clinical and clinical parts would be welcome as well as expanded sessions to directly interact with the regulators.
WP5 published a White Paper, which gives an overview of the current landscape in the member states. WP5 published a Final Report publication, which is closely linked to the STARS Common Strategy. It contains an update and further development of the White Paper’s key steps toward improving regulatory dialogue and highlights the recommendations of the STARS project.
WP6 ensured adequate dissemination and communication, launched the STARS website and organized two European Stakeholder Workshops and a Global Regulatory Science Conference. Due to the Covid-19 pandemic, both workshops were conducted online and the conference in hybrid format. In total, about 100 participants attended each workshop, representing all relevant stakeholders. The aim of both workshops was to discuss and to elaborate the Common Strategy, and to develop strategic recommendations. The results were integrated into the Common Strategy. The global conference took place as a 1-day hybrid meeting in Brussels in May 2022. 60 participants attended the conference in person and 100 participants joined virtually. The aim was to discuss the European experiences in regulatory support and advice for academia and the outcome of the CSA STARS on the international level, and to launch and present the STARS Common Strategy. Furthermore, concepts were discussed and developed to initiate or support a sustainable platform or other formats to enhance interaction and collaborative regulatory research in the future.
