HHS and NIH aim to enhance transparency of clinical trial results

[MeSci]

This is a flying visit as I have masses to catch up on after being offline for 2 weeks. I couldn't see this already posted - apologies if it has been.

U.S. Proposal Would Greatly Expand Transparency of Clinical Trials
By Larry Husten
Edited by
- Susan Sadoughi, MD, and
- Richard Saitz, MD, MPH, FACP, FASAM

The U.S. Department of Health and Human Services on Wednesday proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to report.

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's advocated 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."

Link(s):
NIH news release (Free) http://click.jwatch.org/cts/click?q=227;68095718;jAdKDXklhYDW2U2fUP1Kn3V0KJrnV5KcW8G2oCMoAiM=