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Using the Master Protocol to Obtain Better Clinical Trials for Research

AV submits comments on the Food and Drug Administration’s draft guidance on master protocols for drug and biological product development.

Clinical trials are used to test drugs and biologics for safety and effectiveness. They should be carefully designed, reviewed, and monitored to ensure transparency and accountability. This is to ensure when the Food and Drug Administration (FDA) grants approval for a new therapy, patients, clinicians, and taxpayers have assurances there is complete evidence of clinically meaningful patient outcomes.

The Food and Drug Omnibus Reform Act of 2022 requires the FDA to give clear, updated guidance to streamline the logistics of clinical trials, fostering greater efficiencies in the collection and analysis of trial data. To that end, the FDA has published draft updated guidance for clinical trial master protocols. 

A clinical trial master protocol design offers a detailed plan to better coordinate multiple research goals, for multiple drugs, in various drug-disease pairings. For example, a master protocol could be used in umbrella trials, where many products are tested for one disease, or for platform trials, where many products are tested at different stages of a disease. 

Arnold Ventures recently submitted comments to the FDA, with recommendations to the draft guidance on Master Protocols for Drug and Biological Product Development, recommending that the FDA address both how and when usage of a master protocol is appropriate, with the goal of obtaining better clinical trial designs.

Read our full recommendations here.