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The agency said it intends to release a draft guidance in March 2024 and publish the final guidance in December 2024.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.