The FDA posted a new draft guidance on the use of Master protocols in clinical trials. While starting with defining a number of key terms and types of covered trials, it goes into much further detail o a number of topics including control groups, informed consent, blinding adaptive designs, drug comparisons, safety before delving into trial oversight and data sharing, and then discussing various aspects of interactions with the Agency.
From the draft guidance:
For the purpose of this guidance, FDA defines the following terms:
• Master protocol: a protocol designed with multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more medical products in one or more diseases or conditions within the overall study structure.
• Substudy: the information and design features (e.g., objectives, design, methodology, statistical considerations) related to evaluation of a single medical product in a single disease, condition, or disease subtype in the master protocol.
Examples of trial types that could utilize a master protocol include the following:
• Umbrella trial: a trial designed to evaluate multiple medical products concurrently for a single disease or condition.
• Platform trial: a trial designed to evaluate multiple medical products for a disease or condition in an ongoing manner, with medical products entering or leaving the platform.
• Basket trial: a trial designed to evaluate a medical product for multiple diseases, conditions, or disease subtypes.
Link to Draft Guidance
#FDA #ClinicalTrials #MasterProtocols #DraftGuidance
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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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