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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: 3, Insightful) by Immerman on Monday April 10 2017, @01:29PM (1 child)
Indeed. It's an strategy that is much better suited to "exploratory" research, which is what most medical testing is. However, it does make intentionally biasing the studies easier, and there is already plenty of evidence of repeated dishonest testing by the big pharmaceutical companies.
I could see it working well if we also complemented it by adding the requirement for independent verification of the results before approval. Verification can readily test only the narrow final claims. Just loosening the scientific rigor of the standards though seems like a bad idea.
On the other hand - pharmaceutical companies already cheat routinely, so it could be argued that there isn't actually anything lost.
Perhaps an encouragement to honesty with lower overhead - such as large mandatory fines for any company found to have falsified data or otherwise unfairly biased their research, intentionally or otherwise. Encourage independent review within the company. Make the fines payable directly to the FDA coffers in order to discourage corruption at least at the institutional level.
(Score: 2) by MrGuy on Monday April 10 2017, @02:27PM
I think there's a huge difference when, facing a class action lawsuit, a company can claim "We conducted rigorous scientific studies using industry standard methods overseen and approved by the FDA!" As opposed to "You caught us - we fudged the numbers to get the result we wanted and lied about it in our reports."
It might not reduce liability to zero, but being able to claim with a straight face that you did a scientifically accurate study and the FDA oversaw and approved it is a pretty good defense.