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Member Research & Reports

Member Research & Reports

Johns Hopkins: Most Academic Institutions Unprepared to Meet New HHS Clinical Trial Reporting Regs

Academic institutions have been slow to adhere to new, stricter requirements by the Department of Health and Human Services (HHS) and National Institutes of Health (NIH) for clinical trial registration and reporting, according to a study led by researchers at Johns Hopkins Bloomberg School of Public Health.

For the study, published May 2 in the journal BMC Medicine, the researchers obtained survey data from more than 350 U.S. academic institutions that conduct clinical trials, and found that relatively few had the staff or policies needed to comply with the new requirements.

“Some organizations have good leadership on this issue and are complying with the law, but for many organizations, it seems that their leaders have not taken the necessary steps towards compliance,” says study lead author Dr. 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.”

Traditionally, many clinical trial results have been published without adequate details or have not been published at all, especially if they found no evidence of effectiveness for the candidate treatment tested. However, failing to disclose trial results can lead to unnecessary further trials of the treatment and otherwise allow a false picture of its clinical value.

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