A national survey finds that most academic research facilities were not in compliance with more vigorous, HHS-mandated clinical registration and reporting requirements.
Most academic medical centers and other institutions have been slow to adopt new, stricter federal requirements for clinical trial registration and reporting, a new study shows.
Johns Hopkins Bloomberg School of Public Health researchers obtained survey data from more than 350 academic institutions across the nation that conduct clinical trials. They found that relatively few had the staff or policies needed to comply with the new requirements put forward by the Department of Health and Human Services and National Institutes of Health.
"For many organizations, it seems that their leaders have not taken the necessary steps towards compliance," says study lead author Evan Mayo-Wilson, assistant scientist in the Department of Epidemiology at the Bloomberg School.
"If we want scientists to share their research, then academic institutions need to create systems in which it is expected and easy for individual scientists to do the right thing," Mayo-Wilson said.
Among these 366 organizations that responded to the survey:
- 43% had a policy on clinical trial registration and 35% had a policy on the reporting of trial results.
- Of those with policies, few allowed organizations to punish investigators who failed to register trials or report results—and only one responding organization had ever punished a researcher for non-compliance.
- The responders allocated almost no staff time to ClinicalTrials.gov registration and reporting requirements: The median full-time staff equivalent was just 0.08, implying a single employee was assigned to devote just 8% of her time—a few hours per week—to regulatory compliance.
Inadequate reporting also violates the promise made to trial participants: that the study will help other patients and advance medical knowledge. "If we don't share results, then we’re essentially lying to the people who volunteer for clinical research," Mayo-Wilson says.
The Food and Drug Administration Amendments Act of 2007 requires that sponsors register and report results for many clinical trials. A subsequent final rule expanded these requirements and took effect in April 2017. A complementary NIH policy took effect in January 2018.
The researchers say the findings may represent a best case scenario because the institutions that did not respond are less likely to be in compliance.
Daniel Ford, MD, vice dean for clinical investigation at the Johns Hopkins School of Medicine, said the NIH and the National Library of Medicine could make it easier to comply with the new policies.
"It is the government's responsibility to minimize burden and to ensure that the system is suitable for all the trials that are now required to register and report their results," he said.
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.