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

Discussion in 'Other Health News and Research' started by Denise, Sep 16, 2016.

  1. Denise

    Denise Senior Member

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    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. "
     
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  2. *GG*

    *GG* Senior Member

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    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
     
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  3. Denise

    Denise Senior Member

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    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.
     
  4. trishrhymes

    trishrhymes Senior Member

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    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.
     
  5. CFS_for_19_years

    CFS_for_19_years Hoarder of biscuits

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    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
     
  6. CFS_for_19_years

    CFS_for_19_years Hoarder of biscuits

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

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