HHS, NIH propose changes to make more clinical trial data available

The Department of Health and Human Services and the National Institutes of Health are releasing two proposals for public comment designed to increase the transparency of clinical trials through the submission of data to ClinicalTrials.gov and increase access to clinical trial data.

The first is a notice of proposed rulemaking that describes proposed regulations for registering and submitting results of certain clinical trials to ClinicalTrials.gov that are subject to Title VIII of the FDA Amendments Act of 2007 (FDAAA). It provides proposed interpretations of requirements and practices for submitting registration and results information to ClinicalTrials.gov.

The second proposal is a draft NIH policy that would require similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA.

“Medical advances would not be possible without participants in clinical trials,” NIH Director Francis S. Collins, MD, PhD, said in a press release. “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.”

The proposed changes include:

a streamlined method to determine which trials are subject to the proposed regulations and who is responsible for information submission
expansion to include information from trials of unapproved products
additional data that must be provided at registration and results submission, generally within 1 year of the trial’s end
faster updates to ClinicalTrials.gov
procedures for timely corrections

The proposed changes do not affect the way trials are designed, and would “generally” not include phase 1 data from small trials.

Currently, ClinicalTrials.gov holds registration information for about 178,000 trials, and results data for about 15,000 trials.

“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,” the press release said. “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.”