Integrating randomized controlled trials for drug and biological products Into routine clinical practice (Catapult’s regulatory round-up – September 2024)

As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. Such trials have sometimes been referred to as point of care trials or large simple trials. Comments can be submitted until 17th December 2024. Text published on the 1st of October 2024 in Catapult...