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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.
(Score: 5, Insightful) by BsAtHome on Monday April 10 2017, @09:52AM (2 children)
Rough translation: When a trial is adaptable, then we must correct the course in such a way that our biases and preconceptions are confirmed. There is no real point in doing profitable drugs and studies when your hypothesis is rejected. That only costs money and is not something we like.
There are, of course, rigorous methods to do adaptive trials correct, but I doubt that rigor is the goal for big pharma. Give them a finger and they will grab your hand.
The correct course of action, IMHO, is to have all studies in the open from conception to result. No study should be allowed to meander the path of favoritism for any particular result, especially not when the study may change the parameters.
(Score: 0) by Anonymous Coward on Monday April 10 2017, @01:59PM (1 child)
(Score: 3, Insightful) by DannyB on Monday April 10 2017, @03:51PM
What is this "oversight" word you speak of? Are you referring to some kind of burdensome business-killing regulations?
The lower I set my standards the more accomplishments I have.