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General interest items edited by Janice Flahiff

[News release] Posting of trials results to online public database lagging, say Duke researchers

“What’s published in medical journals doesn’t necessarily match what was reported in clinicaltrials.gov….In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles,”

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From the March 2015 Medicine News post from Duke University

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly atclinicaltrials.govaccording to Duke Medicine researchers.

Among all clinical trials of medical products, those funded by industry were the most likely to be publicly disclosed in a timely fashion, but even then, compliance was poor.

Research funded by the National Institutes of Health and academic institutions lagged further, according to findings published by Monique Anderson, MD, assistant professor of medicine (Cardiology), and her DCRI colleagues in the March 12, 2015, issue of The New England Journal of Medicine.

  • Read the findings: Compliance with Results Reporting at ClinicalTrials.gov.
    From the results section
    “From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.”
  • Read a blog post about the study at Rethinking Clinical Trials, the NIH Collaboratory’s Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical TrialsExcerpts
    ““We were really surprised at how untimely the reporting was—and that more than 66 percent hadn’t reported at all over the 5 years [of the study interval],””Another unexpected result was the finding that industry-sponsored studies were significantly more likely to have reported timely results than were trials sponsored by the National Institutes of Health (NIH) or by other academic or government funding sources. The authors noted that despite a seemingly widespread lack of compliance with both legal and ethical imperatives for reporting trial results, there has so far been no penalty for failing to meet reporting obligations,””reporting clinical trials results in order to contribute to scientific and medical knowledge is as much an ethical obligation for researchers as a legal one: “It’s something we really promise to every patient when they enroll on a trial.””
  • Listen to a report, with quotes from Dr. Anderson and Mark Stacy, MD, vice dean for clinical research, on National Public Radio: Results Of Many Clinical Trials Not Being ReportedExcerpts
    “Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, ”
    “The study doesn’t assess why universities are frequently failing to post their results.”
    “scientists are generally more likely to publish good news and ignore bad news, which skews the scientific record.”
    “What’s published in medical journals doesn’t necessarily match whatwas reported in clinicaltrials.gov.”In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles,” he says.
  • Visit clinicaltrials.gov
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March 15, 2015 - Posted by | Medical and Health Research News | , , , ,

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