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Medical Researchers Lag in Adopting Clinical Trial Requirements

By John Commins  
   May 03, 2018

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.

John Commins is a senior editor at HealthLeaders.


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