EMA Plans New Guidance in Response to Increased Use of Platform Trials
The European Medicines Agency (EMA) is planning to draft new guidance on the planning, operational and reporting challenges inherent to platform trials.
The EMA believes that a “consolidated position” is necessary as industry uses the platform design more and more. Specifically, the agency has begun discussing a guidance on multiplicity and adaptive design that will serve to complement its existing platform trial guidances, not replace or revise them.
Through this guidance, the EMA says it will:
- Clarify terminology and introduce key concepts;
- Describe key methodological topics unique to platform trials and important design features to help guide trial planning and protocol development; and
- Outline the Committee for Medicinal Products for Human Use’s position on the increased complexity and uncertainty in decision-making related to platform trials.
The agency said it intends to release a draft guidance in March 2024 and publish the final guidance in December 2024.
Read the EMA’s concept paper here: https://bit.ly/3i5EAmP.