HHS take steps to provide more information about clinical trials to the public

[Denise]

NIH issued a press release today about the new HHS rules on making study data available.
"In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule (link is external) that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products. At the same time, the National Institutes of Health has issued a complementary policy (link is external) for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. "

 

[*GG*]

NIH issued a press release today about the new HHS rules on making study data available.
"In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule (link is external) that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov.

The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products.

At the same time, the National Institutes of Health has issued a complementary policy (link is external) for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. "

Breaking this up, to make it easier to read, and try to grasp what it is saying. Seems like I will have to hit the links and read that also. Wondering if this adds to the burden or lessens it for those trying to get funding?

GG

 

[Denise]

Breaking this up, to make it easier to read, and try to grasp what it is saying. Seems like I will have to hit the links and read that also. Wondering if this adds to the burden or lessens it for those trying to get funding?

GG

Thanks for breaking this up. (Sorry I didn't do it.)

My sense is that people have known this was coming and this was more formalizing the need for data sharing, than something new and unexpected. How much burden are imposed these new requirements is probably difficult to assess since some groups (Naviaux et al among them) have already been making data available.

 

[trishrhymes]

Sounds like a good start, but I notice it's only trials of drugs and devices, so that apparently excludes psychological studies and exercise etc. Also summary data, not raw data, so inconvenient stuff could be hidden as in the PACE trial, though I know that was UK not USA.

I assume it also wouldn't include studies like the Naviaux metabolomics, because it's not a trial of a treatment.

 

[CFS_for_19_years]

Media coverage in the WSJ:
New U.S. Rule to Expand Requirements for Publication of Clinical Trials
http://www.wsj.com/articles/new-u-s...for-publication-of-clinical-trials-1474040304

Federal health officials will soon be requiring scientists and companies to make public more details of a broader range of medical research studies, even if the results are disappointing to the researchers or to companies sponsoring the research.

A rule published Friday from the Department of Health and Human Services will expand the requirements for clinical trials’ publication to include most studies of products not yet licensed by the Food and Drug Administration. Bolstered by a companion policy announced Friday by the National Institutes of Health, the government beginning next year will require more types of bad side effects to be reported and will set out legal penalties for scientists or companies that don’t comply.

 

[CFS_for_19_years]

STATnews:
New federal rules target woeful public reporting of clinical trial results
https://www.statnews.com/2016/09/16/clinical-trials-reporting-rules

Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.

The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.