Adaptive Trial Designs: Designing Medicines to Fit Patient Profiles.

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  • 07/10/2006

Article today in the Wall Street Journal on the persistent and quiet revolution going on inside the FDA to implement the Critical Path even as the brickbats from Grassley, Waxman, Hinchey and other media hounds come up with 19th approaches for evaluating 21st century medicines.

WSJ(7/10) FDA May Be Open To `Shifting’ Drug Trials
By Anna Wilde Mathews

CLINICAL TRIALS of medicines are traditionally performed in a “blinded” fashion so that the findings will remain secret until the studies are completed. But regulators and the pharmaceutical industry are increasingly interested in starting to use a very different model that lets studies change as they go along, based on early results.

Drug companies have begun to perform such adaptive trials for their new medicines, hoping for more efficient tests that could save millions of dollars. The Food and Drug Administration, meanwhile, is sending increasingly encouraging signs that it is open to considering the results of such trials. In a move that could lay the groundwork for greater future use of such studies, Scott Gottlieb, an FDA deputy commissioner, is set to announce today plans to develop regulatory guidelines for adaptive trials. The FDA has also put together an internal team to work with its drug-review divisions on the adaptive designs, which are statistically complex.

It’s clear what adaptive trial designs can help accomplish: As Peter notes, “Adaptive trial designs represent a major advance in drug safety because the best kind of safety is better understanding of how a drug works *
and who it works best for.”

How? Adaptive trial designs allows researchers to tailor the
study of the drug and its dosing to what they learn about the medicine and
the patient in real time. It’s another tool for personalizing medicine
that the 21st Century Task Force endorsed in is report.

As we pointed out in our recent Washington Times op-ed, the best post market safety is good pre-market surveillance through the use of critical path tools. The battle over FDA reform — and the real end game — how to use user fees — will come down to whether to invest in 21st century or 19th century tools. Spending dough on the status quo won’t cut it.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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