The three-year project will be coordinated by the two German regulatory authorities – the Federal Institute for Drugs and Medical Devices, BfArM and the Paul-Ehrlich Institute, PEI. Its activities will be supported by the DLR Projektträger (DLR-PT), one of Germany’s largest service providers for the funding of research and innovation. The consortium comprises authorities from 18 European countries and is funded by the European Commission with around EUR 2 million.
Improving the regulatory knowledge of academic health researchers will strongly increase the impact of their results and findings for patients and health care systems. One way to achieve this is to improve professional education and provide targeted training programmes. In addition, stipulating academia in regularly asking for scientific advice and continuous protocol assistance in clinical development projects will strengthen successful outcomes and enhance the impact of academic health research for the benefit of the patients.
STARS will coordinate efforts between the national authorities and European partners, relevant initiatives and stakeholders as well as the academic research community, both on the national and the European level. It thus intends to improve the direct regulatory impact of results obtained in medical research.
In the upcoming three years, STARS will
(i) Establish a comprehensive inventory of existing support activities for regulatory scientific advice and protocol assistance in Europe.
(ii) Expand the establishment of best practice examples for efficient support activities and training programmes. It also will provide specific advice and support for the establishment of tailored activities and address the identified gaps.
(iii) Establish a common strategy to strengthen regulatory sciences and improve the support for successful outcomes from regulatory scientific advice, which will be agreed and implemented by the partners of the STARS project.
(iv) Explore and monitor the implementation of a pre-grant regulatory scientific advice on the level of participating Member States. In order to address the identified need to complement, it also will coordinate and harmonize the national and European efforts.
“When regulatory scientific advice is implemented as a core step in the early planning phase of clinical studies in academia, the regulatory compliance and quality of academic driven health research will definitely be improved. The comprehensive and sustainable implementation of regulatory science and support in Europe has a great potential to significantly increase the benefits for patients arising from academic driven research.” (Prof. Dr. Julia Stingl, coordinator of the STARS consortium and Vice president of the BfArM, Bonn, Germany)
The DLR Projektträger (Germany) is partner of the CSA STARS and supports BfArM and PEI as coordinator of this three-year project that is financed by the European Commission. The DLR Projektträger specialises in services for the funding of research, innovation and education. As one of Germany’s largest project management agencies, it supports German state and federal ministries in implementing research funding programmes and operates on behalf of the European Commission, foundations and associations.
Prof. Dr. med. Julia Stingl
Federal Institute for Drugs and Medical Devices (BfArM)
Professor of Translational Pharmacology
University Bonn Medical School