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posted by martyb on Monday April 10 2017, @09:17AM   Printer-friendly
from the draw-curve-then-select-points-to-plot dept.

Scott Gottlieb, President Trump's nominee to run the FDA, is a proponent of adaptive clinical trials, which would allow adjustments of trials as they are ongoing:

In 2006, Scott Gottlieb, then a deputy commissioner at the U.S. Food and Drug Administration (FDA), stood before an audience of clinicians and researchers to sing the praises of a new approach to drug trials. Instead of locking in a study's design from the start, researchers could build in options that would allow them to adjust along the way, based on the data they had collected. They could make the trial larger or smaller, for instance, add or remove arms, or change how incoming patients get assigned to them. Gottlieb predicted such adaptive trial designs, the topic of the conference he attended that distant summer in Washington, D.C., would "tell us more about safety and benefits of drugs, in potentially shorter time frames."

This week, as President Donald Trump's nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of "shorter time frames" for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA's head, as expected, Gottlieb suggested he'd promote wider use of the approach.

But for all their promise, many adaptive trial features still aren't commonplace. And Gottlieb will face a number of obstacles to encouraging their wider use, experts tell ScienceInsider.


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  • (Score: 3, Insightful) by GungnirSniper on Monday April 10 2017, @11:27AM

    by GungnirSniper (1671) on Monday April 10 2017, @11:27AM (#491581) Journal

    Republicans will speak to their base of the business benefits, and Democrats will speak to their base of the safety concerns. He will be approved, but both sides need to use his carcass for promotion first.

    Pharma is one area were we probably have too much regulation now in response to the free-wheeling problems that created weight loss drugs with long-term side effects, or "thalidomide babies" with missing limbs or "flippers". So the balance of cost and risk is eternally in play.

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