Changes in How New Drugs Are Tested

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Janet Woodcock, MD
What we’ve been considering at the FDA as ways to fix this or improve the clinical research enterprise is things like master protocols, whereby a group of clinicians, a network of investigators has a single protocol where they can evaluate multiple investigational drugs over time or at once. Rather than doing a protocol or a clinical trial and another clinical trial for a drug and then you disassemble the whole enterprise and you start over again for the next clinical trial. There are examples that we’ve put together for these and the foundation for NIH, along with a bunch of partners and National Cancer Institute, has something called for example, the lung map trial. Right now they’re evaluating 5 different investigational drugs for squamous cell lung cancer in the same protocol. And the plan is that over time, more investigational agents can be brought into the trial, especially as the others finish their evaluation and maybe move on to get approved or dropout because they didn’t work.