INTRODUCTION
Dear Researchers and Research Coordinators,
As the saying goes, “It takes two to tango.” With that in mind, we invite you to participate in this survey, an integral part of the EU4Health project IncreaseNET to improve regulatory support for clinical research.
IncreaseNET brings together 29 institutions, primarily National Competent Authorities for medicines, from 27 EU/EEA countries and Ukraine. Its mission is to enhance the capacity and competence of the European Medicines Regulatory Network (EMRN) to address the growing number and complexity of regulatory procedures and adapt to the rapid advancements in science.
One of the aims of the project is to improve knowledge about the landscape of academic research in the European Member States to foster early collaboration between drug developers and regulators. This effort seeks to accelerate and optimize clinical research and development of particularly innovative medicines and novel approaches, ultimately ensuring the availability of safe and effective treatments for patients.
Purpose of the Survey
An efficient and effective concept to provide very early advice particularly for academia called “Pre-Grant Regulatory Scientific Advice” (PGRSA) has been developed as part of the previous STARS project co-funded by the European Union (STARS Project).
An efficient and effective concept to provide very early advice particularly for academia called “Pre-Grant Regulatory Scientific Advice” (PGRSA) has been developed as part of the previous STARS project co-funded by the European Union (STARS Project).
This new format is a holistic approach to provide systemically financed early regulatory support for clinical research projects in close cooperation with funding institutions. The format is designed to address scientific and regulatory questions and challenges already at grant application stage. The aim of the PGRSA is to ensure a seamless integration of regulatory requirements at an early stage in the product development in order to support the successful development of particularly innovative medicines on their way to the patient.
The purpose of this survey is to gain valuable insights from your academic perspective on the needs and key criteria to implement/expand the possibility to use PGRSA for tailored first-hand regulatory input to support your performance in building up comprehensive (non-) clinical development.
Why Your Input Matters
By participating in this survey, you actively contribute to build a support system designed around your specific requirements for the PGRSA, e.g. to tailor the scope of the advice, determine the optimal timing, embedded in a best-practice structure. The implementation of such a system aims for the following benefits:
By participating in this survey, you actively contribute to build a support system designed around your specific requirements for the PGRSA, e.g. to tailor the scope of the advice, determine the optimal timing, embedded in a best-practice structure. The implementation of such a system aims for the following benefits:
- provide early regulatory support to prepare for an appropriate clinical trial design
- facilitate first-in-human trial applications (particularly for the innovative approaches)
- avoid project delays by incorporating regulatory requirements early into your project design to a comply with regulatory requirements from the very beginning
- increase the success rate of your grant application by addressing regulatory requirements in your application based on early regulatory advice.
Your perspective is essential to shaping a system that supports academic research and innovation by implementing mechanisms that prioritize the needs of clinical research and patients. By sharing your experiences and insights, you will help create a framework that successfully maximizes the benefits of early and sustainable collaboration between research, regulation and funding.
We believe that the feedback from the questionnaire will provide key insights for the entire research environment and look forward to sharing this important information with you as widely as possible. The results of the survey analysis may also enable us to identify relevant specific aspects/main challenges and invite you to a more in-depth follow-up.