HHS makes clinical trials more transparent

HHS finalized reporting rules on ClinicalTrials.gov to expand and clarify what clinical trial data legally needs to be made public by clinical trial sponsors.

 

Numerof

“Broadly speaking, this announcement is yet another reminder that the government is actively pursuing measures to encourage healthcare improvement and public benefit by increasing transparency and accountability across the industry,” says Rita Numerof, PhD, co-founder and president of Numerof & Associates.

Managed care medical and pharmacy directors will be able to request and expect to receive documentation of more clinical trial results.

“Medical and pharmacy directors will be able to go to ClinicalTrials.govto learn which trials are in process with respect to drugs of interest, and anticipate use of that documentation in pharmacy and therapeutics [P&T] consideration,” says Elan Rubinstein, PharmD, MPH, principal of EB Rubinstein Associates, a pharmaceutical management consulting firm. “While they can do this now, not all clinical trials are currently registered at the ClinicalTrials.gov website.”

While clinical researchers in the U.S. have been required to register trials and report trial information on ClinicalTrials.gov for several years, compliance rates have remained low. According to a study published in PLoS Medicine, the results of clinical trials are going unpublished as much as half the time, and those that are published leave out some key details.

To achieve these goals, the final rule requires the following:

· Interventional trials involving drugs, biologicals, and medical devices must be registered on ClinicalTrials.gov no later than 21 days after the first human subject is enrolled. The rule provides a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information.

· Researchers have one year from a trial's completion date to submit results, including adverse events, and must report any updates to the trial data at least once a year.

· Researchers must provide more information about failed trials.

· Researchers must provide more information about the methodology, results, and participants, including race and ethnicity.

· Researchers will have 90 days to comply after it takes effect and if researchers don’t, they could face civil monetary penalties up to $10,000 a day, and have their federal funding pulled.

However, despite clearly defined repercussions for researchers who violate this final rule, it remains to be seen how closely the government monitors compliance, according to Numerof. “The FDA has indicated that it does not plan to dedicate significant resources to ensure compliance beyond sending ‘warning letters,’” she says.   

According to Numerof, if implemented and enforced properly, this rule has important implications for clinical researchers, including the following: 

· Researchers will no longer have the luxury of deciding which summary results are worth reporting.

· Researchers will need to give greater consideration to whether a trial is worth conducting now that data from even failed studies will be made publically available.

“HHS’ final rule makes information about clinical trials widely available to the public, including patients and providers,” Numerof says. “Expanding information regarding clinical trial registration and results on ClinicalTrials.gov improves patients' ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions.”

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