HHS on Friday unveiled a final rule that aims to make clinical trial results more widely available.
Researchers that receive federal funding are supposed to report their findings on ClinicalTrials.gov within one year of completion. However, a 2014 review of 400 studies found that 30 percent had not reported their results to the website four years after they had been completed. And a separate review of 51 academic medical centers found that 43 percent of their clinical trials were not published two years after they had finished.
"That's clearly unacceptable," NIH Director Francis Collins said. "We, as a community, have a disappointing record of making those results available."
Final rule details
The final rule, which takes effect Jan. 18, 2017, will apply to researchers in most studies of therapies and devices that are funded by NIH or regulated by FDA.
The final rule clarifies that such 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. Researchers will then have one year from a trial's completion date to submit results, and must report at least once a year any updates to the trial data.
The rule also increases the types of research that must be registered and requires more information about the methodology, results, and participants, such as their race and ethnicity.
In addition, HHS is requiring researchers to provide more information about failed trials, which can be helpful for future studies.
HHS said it will provide a web-based checklist tool that trial administrators can use to evaluate whether their trial is subject to reporting requirements.
Researchers will have 90 days to comply with the rule after it takes effect and those that don't comply could face civil monetary penalties up to $10,000 a day, and have their federal funding pulled.
Pharmaceutical Research and Manufacturers of America said the organization is still reviewing the final rule, but added that it supports "enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with the safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research."
Jerry Avorn, a Harvard University medical professor and chief of pharmacoepidemiology at Brigham and Women's Hospital, called the final rule "an important and much-needed development." He said, "Most people don't realize that if a company runs a clinical study of a drug and finds that it doesn't work, or that it has dangerous side effects, until now it's been possible for them to bury those findings."
Suzan Shinazy, founder of the patient advocacy group Medical Errors Transparency Plan, also praised the rule. She said, "I am happy with the NIH and HHS for giving attention to transparency and increasing the public access to current trials and final summary data of other trials," adding, "It seems they are paying attention to the people."
Ben Goldacre, a fellow at the University of Oxford, told STAT News that the efficacy of the new rule would depend on the degree to which FDA and NIH enforce it.FDA Commissioner Robert Califf said he thinks most compliance issues will be fixed by the agency sending warning letters, and that he doesn't "think anybody wants to be on the wall of shame" and have a notice on ClinicalTrials.gov that their study is in violation of federal law. He added, "We're not going to have a vast army to pursue the compliance issues, but we really don’t think that (will be) necessary" (Bernstein, "To Your Health," Washington Post, 9/16; AP/Sacramento Bee, 9/16; HHS final rule, 9/16; Rubenfire, Modern Healthcare, 9/16; Burton, Wall Street Journal, 9/16; Piller, STAT News, 9/16).
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