September 23, 2016

Feds Add Teeth to Clinical Trial Data Sharing Rules

The Department of Health and Human Services has published new regulations and guidance to enhance clinical trial reporting requirements and subject non-compliant entities to penalties including the potential loss of federal grant money.

The new policies are intended to encourage greater participation in clinical trials and to promote dissemination of trial results so patients can more quickly garner the benefits from research findings.

The rule expands and clarifies which trials are required to submit data to Entities that are subject to the rule will have 90 days after its Jan. 18, 2017, implementation date to come into compliance. Among the requirements:

  • Clinical trials must be registered within 21 days after the first human subject is enrolled
  • Summary results must be submitted within one year of the study’s completion
  • Protocols must be posted
  • Adverse events must be disclosed
  • Race and ethnicity information must be included in results
Entities with trials that do not comply with the data reporting requirements may be subject to penalties, such as civil monetary penalties of up to $10,000 per day, loss of current and future federal funding and possible criminal penalties for making false statements to the Government.

Although the policies have been under consideration for several years, with publication of a proposed rule in 2014, the final rule aligns with priorities set forth by Vice President Joe Biden as part of the Cancer Moonshot initiative.