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    ‘Scorecard’ Reveals Findings from Many Pain-Related Clinical Trials Never Made Public

    Study shows patients and their doctors unable to locate
    potentially important drug information

    Contact: Amy Weitz, 510-206-1855

    San Francisco, CA, July 30, 2012 – An analysis of more than 200 completed clinical trials for pain shows that results appear in a peer-reviewed journal less than half the time, and for about a third, results cannot be found in any publicly accessible document. The upshot is that patients dealing with intractable pain – and their doctors – are unable to access information that could be important to have when deciding on treatment options.

    The study’s research team, from the California Pacific Medical Center Research Institute (CPMCRI, part of the Sutter Health network) and the University of Rochester School of Medicine and Dentistry, produced a scorecard after analyzing the federal database of all clinical (human) trials across three of the most frequently studied chronic pain disorders: postherpetic neuralgia (PHN), which is nerve pain resulting from shingles; fibromyalgia; and diabetic peripheral neuropathy (DPN). The report, the first of its kind involving analgesic clinical trials, will appear in the September 2012 issue of the journal PAIN, published by the International Association for the Study of Pain.

    “What this scorecard tells us is that a lot of potentially useful information is just sitting in files gathering dust,” said Michael Rowbotham, MD, an author of the study who is a neurologist and the scientific director of CPMCRI. “But this information could be helping patients and their doctors make better decisions about which pain-relief medications to use – or not to use. Given the great difficulty that many people have in finding safe and effective means to control their pain, we can’t afford to leave any stone unturned when looking for answers,” he added.

    The researchers reviewed the federal registry of all clinical trials for PHN, fibromyalgia and DPN and identified the 228 that had been completed. They then investigated which of those trials had results reported in a peer-reviewed journal, which trials only appeared in what is known as “grey literature” – places such as press releases, posters presented at a scientific conference, or other venues that can be difficult if not impossible to locate through search efforts – and which trials could not be located anywhere at all.

    Of all the completed trials, only between 39% and 44% (depending on which of the three pain categories was involved) had their results reported in a peer-reviewed journal. After an extensive search of the grey literature for results, the figure rises to 63% - 68% overall. The comprehensive search strategy used by the researchers could not find any results for the remaining trials.

    “The public, and also the scientific community, have difficulty finding study results in the grey literature. But the lack of adequate analysis or peer review in the grey literature make the data suspect in any case,” said Dr. Rowbotham.

    Selective publication favors positive results, creates ‘file drawer’ effect

    Although the scorecard does not reflect the breakdown of positive vs. negative results that were reported, previous studies have shown that trials with positive outcomes are much more likely to be published in peer-reviewed journals. But negative studies can reveal valuable information about the safety or efficacy of the potential remedy.

    The scorecard offers clues about the extent to which “selective publication” may exist – where publication of research is determined by the nature of the results. Researchers and editors tend to treat positive results differently than they do negative or inconclusive research, leaving the latter group in what has been called a figurative ‘file drawer.’

    “Researchers, especially those involved in drug trials, need to improve their track record in publishing their results, no matter the outcome,” said Dr. Rowbotham. “Many important nuggets are hidden away, and they need to become easier to find. In this day and age, when the Internet has made everything infinitely easier to locate, no one with access to a computer should have trouble finding information online.”

    The study, called “A snapshot and scorecard for analgesic clinical trials for chronic pain: The RReACT database,” was first presented as a poster at the Annual Scientific Meeting of the American Pain Society in May 2012 in Honolulu. The trials in the study took place between 2003 and 2011. The authors are Kaitlin Greene, Robert H. Dworkin and Michael C. Rowbotham. The project was funded as part of the Analgesic Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) initiative, a public-private partnership between the FDA, the National Institutes of Health, industry, and academia. The article will appear in the September 2012 issue of the journal PAIN (Vol. 153, Issue 9).

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