November 19th, 2014
U.S. Proposal Would Greatly Expand Transparency of Clinical Trials
Larry Husten, PHD
The U.S. Department of Health and Human Services today proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to report.
“Medical advances would not be possible without participants in clinical trials,” said NIH Director Francis Collins. “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”
Currently, researchers are required to publish information on ClinicalTrials.Gov, the public database run by the National Library of Medicine, about studies involving drugs, biological products, and devices that are regulated by the FDA, but these regulations do not apply to phase 1 trials of drugs and biological products and small feasibility studies of devices. The new rule would expand the reporting requirements to include all trials of unapproved, unlicensed, and uncleared products. A second proposal would also require the publication of all clinical trials funded by the NIH.
“This is a great day for research in America,” said Harlan Krumholz, who has been an advocate for greater transparency. “NIH is exhibiting extraordinary leadership in exerting their influence to promote the responsible conduct of research for anyone receiving their funds. It’s a day to applaud these actions.”
A statement from the NIH explained the benefits of increased transparency:
Among the primary benefits of registering and reporting results of clinical trials, including both positive and negative findings, is that it helps researchers prevent unnecessary duplication of trials, particularly when trial results indicate that a product under study may be unsafe or ineffective, and it establishes trust with clinical trial participants that the information from their participation is being put to maximum use to further knowledge about their condition.
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