FDA Draft Co-Development Guidance Emphasizes Phase II Studies
Clinical trial strategies proposed in FDA's draft guidance for co-development of drugs designed for use in combination in most cases whittle the design down to standard of care versus the combination before Phase III, offering the prospect of cutting not only development time but also clinical trial costs.
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In a final guidance on co-development of two or more investigational new drugs for use in combination, FDA lays out general principles for IND and marketing application submissions, a topic on which the agency essentially punted in a December 2010 draft document.
CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.
FDA put together its well-received draft guidance on co-development of experimental drugs to be used in combination in less than a year, but even with regulators on board and the science burgeoning, the timeline for finding predictable ways for companies to actually collaborate on combining investigative cancer therapies looks to be much longer.