Periodic Reporting for period 2 - STARS (Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS))
Periodo di rendicontazione: 2020-07-01 al 2022-06-30
Academic groups play an essential role in the development of new drugs, vaccines and (digital) medical devices. However, on the long way to the patient there is still a large translational gap since not all academic-driven research will pass the scrutiny of the regulatory authorities or the market access. This has been identified as a deficiency by the EC and many national funders across Europe and beyond.
The overarching goal of STARS is to advance the regulatory impact of academic-driven health research in order to accelerate innovation for the benefit of patients and society by sharing knowledge on regulatory science, processes and needs. STARS aimed at improving regulatory support activities and education to enhance successful outcomes of regulatory scientific advice procedures. To this end, STARS pursued specific activities, including support tools such as a comprehensive inventory to assist European academic drug developers in finding support on regulatory affairs, recommendations on curricula to be implemented in (bio)medical educational programmes, a white paper that highlights key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities, as well as three pilot projects to support academia to demonstrate that selected support activities can be implemented efficiently.
The overarching goal of STARS is to advance the regulatory impact of academic-driven health research in order to accelerate innovation for the benefit of patients and society by sharing knowledge on regulatory science, processes and needs. STARS aimed at improving regulatory support activities and education to enhance successful outcomes of regulatory scientific advice procedures. To this end, STARS pursued specific activities, including support tools such as a comprehensive inventory to assist European academic drug developers in finding support on regulatory affairs, recommendations on curricula to be implemented in (bio)medical educational programmes, a white paper that highlights key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities, as well as three pilot projects to support academia to demonstrate that selected support activities can be implemented efficiently.
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.
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.
The project improved regulatory education and knowledge to support patient access to innovative treatments, by focussing also on all other kinds of support activities suitable to enhance success and outcome during regulatory scientific advice procedures. STARS coordinated efforts between the NCAs and European partners, relevant initiatives and stakeholders, and the academic research community on national and European level. The project addressed two 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 and society by sharing knowledge on regulatory science and by supporting validation/qualification of innovative clinical endpoints such as surrogate outcomes for response or predicting patient profiles for safety. With the EU Innovation Network in place, the implementation of the recommendations, especially those to regulators, is well supported and sustained.