Issue Date: September 18, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Real World Data / Real World Evidence (RWD/RWE),
Status: Draft
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry
As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection,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. Like decentralized clinical trials, which aim to bring trial-related activities to patients’ homes or other convenient locations, such RCTs may improve convenience and accessibility for participants and allow for enrollment of more representative populations, resulting in more generalizable trial results. Leveraging established health care institutions and existing clinical expertise in the medical community can reduce startup times and speed up enrollment.
Download the Guidance Document
