EMA Review to Identify Faults in Phase 1 Trial Guidelines

EMA is reviewing its guidelines for Phase 1 trials in the wake of a fatally flawed French study, with an eye toward issuing proposed revisions in July.

The agency has convened two teams of experts for the review, one focusing on pre-clinical issues and the data needed to safely initiate Phase 1 trials, while the other group will consider ways to improve trial design to better ensure participant safety, the EMA announced.

This dual-path review is expected to produce a concept paper of proposed changes in July, which itself is intended to spur an EU-wide discussion for revising the guidelines.