This draft reflects changes based on comments submitted to the December 21, 2023 draft guidance that is for clinical trials operating under a master protocol. The introduction notes three examples of trial operating under a master protocol: umbrella, basket and platform.
The Introduction also notes:
"The primary focus of this guidance is on randomized trials using a master protocol that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness of a drug. The concepts discussed may also be useful to consider for early-phase or exploratory trials under a master protocol as well as those conducted to satisfy post-marketing commitments or requirements. The recommendations and considerations in this guidance may not apply to master protocols evaluating first-in-human drugs, given the unique attributes from both a trial design and regulatory perspective that must be considered."
In addition to discussions on the traditional content and operation of clinical studies, the guidance ends with a section on "CONSIDERATIONS TO SUPPORT REGULATORY REVIEW" - an interesting section with lots of guidance for the entire development pathway.
#fda #MasterProtocols
Master Protocols for Drug and Biological Product Development
| U.S. Food and Drug Administration |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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