HHS Expands Rules for Clinical Trial Reporting

The federal government has adopted new policies to clarify and expand the reporting requirements for clinical trials and to make the data available more quickly to researchers and the public. Noting that previous rules were ambiguous and often ignored, federal officials vowed to enforce the new requirements and pull public funding from studies that do not comply.

The new rules from the U.S. Department of Health and Human Services (HHS) and the NIH, which take effect on January 18, 2017, outline the requirements for registering and submitting summary results to ClinicalTrials.gov for all publicly funded trials. Key changes include mandatory registration of trials that test experimental and early-stage therapies, and posting results for trials of unapproved drugs.

The rules also clarify the definition of an Applicable Clinical Trial and provide a checklist of mandatory data requirements for registration, such as information about the design and outcome measures and recruitment eligibility criteria. In addition, more information must be submitted on completed trials, including demographic characteristics of participants and details of any adverse events that affect more than 5% of patients. The key points are described in The New England Journal of Medicine (N Engl J Med 2016 Sept 16 [Epub ahead of print]).

“Sharing results is society's responsibility toward the volunteers who agree to participate in trials,” said NIH Director Francis Collins, MD, PhD, at a press conference, “but we as a community have had a disappointing track record at making those results available.”

Under the existing rule, researchers must submit results of federally funded research within a year of completing a trial, but that often doesn't happen. Collins cited a recent study showing that among trials conducted at 51 U.S. academic medical centers, 43% had not published their results within 2 years of completion (BMJ 2016;352:i637). A separate review of 400 studies found that 30% had not reported results within 4 years (PLoS ONE 2014;9:e101826).

Officials anticipate a flood of new trial registrations as a result of the ruling, said Collins, and the FDA is making plans to strengthen enforcement.

Sponsors of publicly funded studies that do not comply will face stiff penalties, including fines and withdrawal of funding for future trials, noted FDA Commissioner Robert Califf, MD, during the news conference. The FDA plans to fold compliance and enforcement activities into its existing Bioresearch Monitoring program, through which it collects clinical trial information during site inspections.

“We are already at a number of these trial sites on a routine basis,” Califf noted. “Once people realize how serious this is, we don't think that we will have a lot of problems with compliance. No one wants to be on the “wall of shame' for failing to report their results.” –Janet Colwell