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Study finds outcome data in clinical trials reported inadequately, inconsistently
Date:5/14/2014

Philadelphia, May 14, 2014 There is increasing public pressure to report the results of all clinical trials to eliminate publication bias and improve public access. However, investigators using the World Health Organization's International Clinical Trials Registry Platform (ICTRP) to build a database of clinical trials involving chronic pain have encountered several challenges. They describe the perils and pitfalls of using the ICTRP and propose alternative strategies to improve clinical trials reporting. This important and insightful study is published in the August issue of the journal PAIN.

U.S. law already requires posting summarized results on ClinicalTrials.gov, a service of the National Institutes of Health, within one year of study completion for certain categories of industry-sponsored trials. Legislation mandating data publication within one year of study completion, irrespective of outcome, is under consideration in the European Union. Yet compliance with the U.S. law is poor.

"Although clinical trial registries facilitate public access to basic trial information, we found that access to unbiased trial results is still inadequate. A distressingly large number of trials have no published results at all or are mentioned only in sponsor press releases. Recent analyses have found that only 25-35% of clinical trials required to post study results on ClinicalTrials.gov actually do so," comments senior investigator Michael C. Rowbotham, MD, scientific director of the California Pacific Medical Center Research Institute in San Francisco.

The investigators drew on their experience with the Repository of Registered Analgesic Clinical Trials (RReACT) database, a scorecard for analgesic clinical trials for chronic pain (sponsored by an FDA grant to the University of Rochester), to describe the challenge of constructing a global open-access database of clinical trials and trial results. They focused on three frequently studied
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Contact: Terry Materese
painmedia@elsevier.com
215-239-3196
Elsevier Health Sciences
Source:Eurekalert

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