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GUIDANCE DOCUMENT

Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft Guidance for Industry September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2052

Docket Number:
FDA-2024-D-2052
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Oncology Center of Excellence

As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection,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.  

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