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HHS and NIH Announce New Requirements for Clinical Trials in an Effort to Improve Access and Data Sharing

December 30, 2021

The U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) announced new requirements for registering and reporting clinical trial results on, and reporting those results to the public. HHS hopes to increase the number of patients with cancer who participate in clinical trials, as many clinical trials fail because they do not meet enrollment targets and cannot provide meaningful results on a potential treatment. The policy changes were created to help patients and practitioners locate appropriate clinical trials, with some new rules including:

  • requiring that clinical trials be registered on within 21 days of enrolling the first participant
  • requiring that clinical trial results be published within 12 months of collecting the last data point – for trials with both positive and negative outcomes
  • withholding funding to institutions that receive federal grants for clinical trials that are not adequately registered or reported on
  • allowing third-party sites to provide information to their constituencies through a new application programming interface that allows patient advocacy groups, cancer centers, and researchers to build web applications and search engines to improve access to clinical trial information

These rules do not extend to smaller trials such as phase I and feasibility studies.

The rules were developed based on the 900 comments received during a public comment period. Read the HHS final rule.

The NIH also announced that it will require researchers who receive federal funding from the agency to submit a plan outlining how data gleaned from the government-backed project will be shared with the public. Open data-sharing is a tenet of Vice President Joe Biden's Cancer Moonshot Initiative, which strives to increase access to clinical trials and encourage data sharing as part of its mission.

"We are going to expect applicants who are generating data sets to produce a data-sharing plan or we are not going to fund them," said NIH Director Francis Collins, MD, PhD. "And for applicants who have failed to live up to their responsibilities for data sharing, that will hurt them in their next opportunity to get funds from NIH."

Dr. Collins did not provide a firm date for when the new policy would be implemented across the agency, but said that NIH is in the "middle of figuring out how to regularize that" across the different NIH centers.

Data sharing has become a controversial topic recently, raising questions about accuracy, authenticity, and ownership. The editors of the New England Journal of Medicine, for example, introduced the concept of "research parasites" earlier this year in an editorial claiming that open sharing of data could lead to scientists using another group's data for their own gain.

Source: National Institutes of Health news release, September 16, 2016 and November 3, 2016.


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