A proposal is being floated to make clinical trial results posted to ClinicalTrials.gov more transparent, complete, and timely, regardless of whether the trial is related to an approved product.
The Department of Health & Human Services posted a proposed rule for public inspection on Nov. 19 that would expand the reporting requirements for ClinicalTrials.gov to include results on all clinical trials that are required to register on the trials database, not just results for drugs and devices that are approved, licensed, or cleared for use. It also expands data elements that are accessible and proposes more frequent updating for certain data.
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Comments on the proposed rule are due within 90 days of its publication in the Federal Register on Nov. 21.
Other than phase I studies of drugs and biologics and small feasibility studies of devices, trials involving drugs and devices regulated by the Food and Drug Administration would be subject to the reporting requirement under this proposal, irrespective of who is funding the study.
A separate proposal by the National Institutes of Health would apply the expanded reporting proposal to all trials funded by NIH, regardless of whether those trials would otherwise not be required to report to ClinicalTrials.gov under requirements set in the FDA Amendments Act of 2007.
“The scientific community has a disappointing track record for dissemination of clinical trial results,” NIH Deputy Director for Science, Outreach and Policy Kathy Hudson, Ph.D., and Director Dr. Francis Collins wrote in a viewpoint published in JAMA (2014 Nov. 19 [doi:10.1001/jama.2014.10716]) .
The NIH officials noted that a “recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.”
Comments on the proposed rule are due within 90 days of its publication in the Federal Register on Nov. 21. The response date for comments on the NIH draft policy on reporting requirements for NIH-funded studies is Feb. 19, 2015.