Learning from European regulator-initiated studies for regulatory decision making.

Abstract

Drug developers have displayed a growing interest in using real-word evidence (RWE) in the pre-marketing phase. Together with initiatives like DARWIN EU®, this interest encourages regulators to initiate their own observational clinical studies, which could be included in regulatory decision making. The Regulatory Science Network Netherlands organised an expert meeting in 2022 to discuss scenarios and learnings related to these regulator-initiated studies, of which the main points (e.g., transparency, independency and stakeholder interaction) have been published previously. In this review, the authors add their own views, underlining the importance of reproducibility and stakeholder interaction. Stakeholders should collaborate to embrace regulator-initiated studies in a timely and transparent manner to realise an optimal European framework for generating RWE to be included in the regulatory decision-making process.