STARS

Initiative leader: Federal Institute for Drugs and Medical Devices (BfArM) - Germany

Duration: January 2019 – June 2022

Limited knowledge in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aimed to analyse the current situation and improve the training of academia in regulatory sciences and thereby further enhance regulatory knowledge.

The overall goals of STARS also comprised strengthening academic, regulatory science on national and European level, as well as improving success in regulatory Scientific Advice and Protocol Assistance of academic driven health research. The vision was to advance the direct regulatory impact of results obtained in medical research by professional education and targeted training programmes for academic scientists. Additional activities, such as support for successful outcomes in scientific advice and protocol assistance in clinical development projects, aimed to help academic health research reach its full impact and benefit for the patient.

During the 3 years project period, STARS:

1. established a Comprehensive Inventory of existing support activities for academic researchers, in order to improve success during Scientific Advice and Protocol Assistance procedures;
2. expanded the establishment of best practice examples for efficient Support Activities / training programmes and by providing specific advice and support for the establishment of tailored activities and addressing the identified gaps;
3. established 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.
4. explored and monitored the implementation of a pre-grant regulatory scientific advice on the level of participating Member State also, in order to address the identified need to complement, coordinate and harmonise the national and European efforts.

ECRIN's Role in STARS

ECRIN contributed in panel discussions and impulse notes at two workshops “Towards an Improved Strategy for Regulatory Support for Academia “and “Towards a Common Strategy to Empower Academia in Regulatory Awareness and Knowledge” representing academic researchers, amongst other stake holders like for example national clinical centres, clinical research networks, funding bodies, regulators from national competent authorities, patient representatives, and industry representatives.

This project has received funding from the European Union’s Horizon 2020 programme under grant agreement number 825881.