Editor’s note: After this story was published, we learned that we mistakenly counted some studies as violators of the reporting law because they were not included on a list of exempt studies provided to STAT by the National Institutes of Health. Before publication, NIH had described this list as a complete accounting of exempt trials. But an agency official subsequently told us that organizations running studies completed before Jan. 18, 2017 — when new ClinicalTrials.gov regulations went into effect — could delay reporting the results without seeking a formal exemption, if the drug being tested had not been approved by the Food and Drug Administration. For such studies, requesting a formal “certification for delay” was optional, the official said. Unfortunately, this means that for many older trials, there is no practical way for STAT or anyone else to verify which ones are exempt, but this story and the accompanying data visualization remain the most accurate assessment possible. Based on this new information, we have created a separate list of trials that sponsors say were unapproved and thus exempt, and have linked to any documentation provided by the sponsors. STAT has not verified these claims. Sponsors can submit information here. Thankfully, this transparency loophole has been partly fixed under the new rules, and for trials completed since Jan. 18, 2017, you can check this TrialsTracker website to determine whether the results are overdue. (The details of that site’s methodology are here.) You can also read a detailed description of the methodology STAT used to analyze the ClinicalTrials.gov database here.

The reporting of clinical trial results to a public database — mandated by a 10-year-old federal law — has improved sharply in the last two years, with universities and other nonprofit research centers leading the way, according to a new STAT analysis of government data.

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  • Scott A, Rucklidge JJ, Mulder RT. Is mandatory prospective trial registration working to prevent publication of unregistered trials and selective outcome reporting? An observational study of five psychiatry journals that mandate prospective clinical trial registration. PLoS One. 2015;10(8):e0133718.

  • In the spirit of transparency, release your entire database in Excel publicly. Hovering over thousands of trial ‘circles’ to amass the information is onerous.

  • This “article” reports to relate to “legal compliance” yet seems to ignore many aspects of the law.

    This “article” disregards that many studies that are registered voluntarily on CT.gov do not need to have results disclosed per the LAW (as there were not applicable trials) and in these cases results from these studies are instead posted on other registers, company or institution websites, or are published in journals. Also study results posting is not required by LAW until approval (actually 30 days after approval) for a given indication, this too is ignored by this “article”. By my estimate (and those of other researchers such as Jennifer Miller) companies are more like 98% compliant with the law while this article is reporting 30-50 compliant in many cases. In fact this article is attacking those companies and institutions that historically went “above and beyond” legal requirement by registering additional studies voluntarily (or to meet journal requirements)…

    In an era of fake news and pressures on RESPONSIBLE free press this is dangerous sensationalism based on lack of rigor to actual legal requirements and FACTS. If this article is indeed about companies and academic institutions LEGAL compliance then it should have the scientific rigor to evaluate vs the legal requirement. Please focus on the law and look more deeply in those areas where of course we should all be concerned.

    All those below applauding this article may need to dig a little deeper and hold your applause.

    • There are also some non-public factors at play. For instance if the Sponsor delayed results posting, they may not be considered late, but STAT wouldn’t know that. I would imagine a disclaimer should at least be footnoted…

    • Yes, Brice, some datapoints were not available for download from ClinicalTrials.gov – like data that would have allowed us to exclude from the violator’s list, studies that had received an official reporting extension. To eventually receive this data, STAT filed a separate request with ClinicalTrials.gov. We are preparing a more detailed explanation of our data analysis and a step-by-step guide to using our full dataset with links to some additional spreadsheets, which will be publishing shortly.

  • This is journalism at its very best. Congratulations!
    It would be fantastic if you could also link the full results in Excel or similar format for downloading.

  • Good research and good article. Are there, or do there need to be, fines, sanctions, repayment of grant dollars with interest, or even stiffer penalties? Taking government research funding and not delivering the required reporting sounds like a breach of contract or even a form of graft. This does not pass muster in the corporate or nonprofit sector, and should not pass muster in government.

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