Drug Sponsors Urge FDA to Think Bigger About Master Protocols
Leading drugmakers are urging the FDA to think bigger about its master protocol guidelines for clinical trials and expand beyond cancer trials.
In September, the agency issued a draft guidance on master protocol design, hoping to encourage sponsors to use more adaptive trials and speed life-saving anticancer drugs to market.
In comments on the draft, Pfizer, Novartis and Regeneron urged the agency to look beyond cancer for master protocol designs. Regeneron said the use of master protocols in rare diseases presents a good opportunity to expedite orphan drug development. Novartis suggested that the FDA work with the Oncology Center of Excellence, CDER and CBER to identify areas where more flexible trial designs might be effective.