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article imageHealth agencies push for data disclosure

By Tim Sandle     Dec 6, 2014 in Health
Washington - Two U.S. federal health agencies have released proposed rules that would tighten the requirements for reporting clinical trial results.
The reason why this move is important is because the results of medical experiments on humans are rarely released into the public arena. As an example, according to the U.S. National Institutes of Health (NIH), of the 178,000 clinical trials registered at clinicaltrials.gov, just 15,000 summary results have been published there. The new rules, if adopted, would expand the mandate for posting the results of clinical trials to those studies that include surgical techniques and therapies that don’t gain approval. The rules would also require that more data be deposited, in a more timely fashion.
Drug regulators in Europe and the U.S. have been pushing for more disclosure and for results to be reported in a faster way.. In the latest step in this on-going tussle with big pharma, the NIH and Food and Drug Administration (FDA) have proposed more expansive requirements for clinical trial data to make it into the online trial repository clinicaltrials.gov.
Commenting on the latest action, NIH Director Francis Collins and Deputy Director Kathy Hudson wrote at the NIH Director’s Blog: “To honor [trial] participants’ selfless commitment to advancing biomedical science, researchers have an ethical obligation to share the results of clinical trials in a swift and transparent manner...Unfortunately, the timely public reporting of results has not been consistent across the clinical trials enterprise.”
Adding opinion to the discussion, Peter Doshi of the University of Maryland School of Pharmacy told The Wall Street Journal’s Pharmalot: “Clearly, it’s important as ultimately the rules surrounding ClinicalTrials.gov affects healthcare providers’ ability to accurately assess the risk and benefits of interventions.”
The issue is set to run, with some parts of the pharmaceutical world reluctant, for commercial reasons, to disclose any further information.
More about Health, Data, data disclosure, freedom of information act
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