Tuesday, May 30, 2017

Government Policies Seek to Make Findings from Clinical Trials More Widely Available

Originally published by Robert Kraft.


In “To Your Health,” the Washington Post reported that, “the government unveiled new policies” intended “to make findings from clinical trials of therapies and devices more widely available, warning that it would block future funding for universities and other institutions that do not comply.” Starting “on Jan. 18, researchers in most studies of therapies and devices funded by NIH or regulated by the” FDA “will have 90 days to come into compliance with the new rules.” During “a briefing for reporters,” Francis S. Collins, director of the National Institutes of Health, said, “We, as a community, have a disappointing record of making those results available.” Collins added, “This is about maintaining the trust that we have with participants in clinical trials who volunteer to take part in these efforts with the expectation that it will add to the body of knowledge.”

Bloomberg News reported that in a call with reporters, FDA Commissioner Robert Califf said, “If it’s not a good clinical trial, we’re saying you’ve got to put it out there anyway. It’s going to lead people to do things more thoughtfully, and I think the quality of the trials will get better.” Bloomberg News points out that “NIH first proposed the rule in 2014, and the final version released Friday is similar to the draft, said Kathy Hudson, the deputy director for science outreach and policy at NIH.”

On its website, CBS News reported that Califf said, “This, is in my view, is a really exciting statement that we’re going to hold true to that pledge we make when we do research on people, to make that general knowledge available.” Meanwhile, Collins said, “Our goal is to have all NIH-funded trials in ClinicalTrials.gov.” This “new policy ‘has some teeth,’ he added, and will help maximize the value of clinical trials, whether publicly or privately funded.”

From the news release of the American Association for Justice.

Curated by Texas Bar Today. Follow us on Twitter @texasbartoday.

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