FDA Eager For More Master Protocols in Oncology: Approach Means Lower Cost For Sponsors—and Less Control
This article was originally published in RPM Report
Executive Summary
FDA officials are enthusiastic about broad, multi-agent cancer trials built on the I-SPY model. For sponsors, the trials mean less control over the development path and ultimate value proposition for the therapy—but may have important benefits on defending high prices for truly effective new therapies.
You may also be interested in...
Ebola Outbreak Draws Investor Attention; Real Impact May Be Clinical Trial Models
The race is on to develop Ebola treatments and vaccines. Investors have noticed. But the biggest impact on drug development from the Ebola outbreak may be innovation in clinical trial models – not therapeutics.
Hill Hearing Casts Spotlight On FDA Drug Approval Process
FDA’s Janet Woodcock defends the agency against criticism its review process is too slow; Congressman says FDA should proceed with antibiotic development program without waiting for new statutory authority.
Lung Cancer “Master Protocol” Eyed As Paradigm-Changing Approach To Drug Development
The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.