Health Officials Propose Increased Transparency In Clinical Trials

By Chuck Seegert, Ph.D.

Health officials are proposing a significant increase in the reporting requirements for clinical trials used to test drugs, medical devices, and other interventions. The potential new regulations are aimed at preventing unnecessary trial duplication and ensuring that results from human subjects are put to the greatest possible use.

Clinical trials are an essential way of testing new medical devices, drugs, and other treatments that will be used in the human population. Currently, a clinical trial can be conducted and, in many cases, results from that trial do not have to be disclosed. This has raised questions about trials that have had negative results, since information from those trials could be used by other researchers  to avoid similar failures in their own programs.

For example, in 2013 researchers discovered that out of the hundreds of trials, at least half of them never published results, according to a recent story from Reuters. With the current rules, data from trials can remain secret if it is found that a device or drug is ineffective.

“This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public,” said FDA commissioner Margaret A. Hamburg, M.D., in a recent press release from the National Institutes of Health (NIH). “It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.”

The proposed changes will apply to clinical trials subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), according to the press release. The new language is designed to clarify requirements for clinical researchers who will register trials with ClinicalTrials.gov and then submit results.

Currently, many clinical trials are registered and have reports archived at ClinicalTrials.gov, a database operated by the NIH, according to Reuters. Of the 178,000 clinical trials that are currently registered, 15,000 of them have published summary results, according to the NIH.

A summary of proposed changes to the reporting rules from the NIH press release are listed below:

• A streamlined approach for determining which trials are subject to the proposed regulations and who is responsible for submitting required information
• Expansion of the set of trials subject to summary results reporting to include trials of unapproved products
• Additional data elements that must be provided at the time of registration (not later than 21 days after enrolling the first participant) and results submission (generally not later than 12 months after completion)
• Clarified procedures for delaying results submission when studying an unapproved, unlicensed, or uncleared product, or a new use of a previously approved, licensed, or cleared product, and for requesting extensions to the results submission deadline for good cause
• More rapid updating of several data elements to help ensure that users of ClinicalTrials.gov have access to accurate, up-to-date information about important aspects of a clinical trial
• Procedures for timely corrections to any errors discovered by the responsible party or by the Agency as it processes submissions prior to posting

Further information on the proposed rule changes for clinical trial reporting can be viewed in another news release from the NIH.