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Circling the Dome

100% Compliance Wasn’t Easy

Earlier this year, The Johns Hopkins University became one of the nation’s first academic medical centers to fully comply with a federal law that requires researchers to provide results of human studies that help evaluate new medical, surgical and behavioral interventions.

But reaching 100 percent compliance on ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world, wasn’t easy, says Anthony Keyes, a program manager for clinical research projects for the Johns Hopkins Institute for Clinical and Translational Research (ICTR) who was charged with getting Johns Hopkins’ information up to date.

ClinicalTrials.gov was created as a resource for patients, physicians, regulators and funders to stay informed about cutting-edge clinical trials; and the website began sharing results with the public in 2005. The effort to collect clinical trial data in one place drew praise around the world from the scientific community. Many journals and funders have amended their policies to make research transparency a condition of publication or future funding.

But despite the enthusiasm, researchers found the federal regulations confusing and the ClinicalTrials.gov site cumbersome. Without enforcement, the regulation served more as guideline than gospel, and many important trials went underreported — or not reported at all.

The Food and Drug Administration (FDA), tasked with enforcing the compliance law, informed researchers two years ago that they’d soon face penalties as high as almost $12,000 per day for failure to submit their clinical trial results. Furthermore, the National Institutes of Health said it was considering making compliance a condition of future funding. Johns Hopkins, which for 39 consecutive years has been the top recipient of federal research funds, received nearly $2.2 billion in government funding in 2017.

“The FDA isn’t kidding around,” says Keyes. “We’ve known this accountability was coming for a long time. There really aren’t any excuses anymore.”

Johns Hopkins was among many leading U.S. research centers with dramatic gaps in its reporting. A January 2018 STAT article reported that 84 percent of clinical trials that Johns Hopkins conducted between 2008 and 2017 were reported past the FDA’s deadline or not at all. But by March 2019, thanks to ICTR, all Johns Hopkins researchers had uploaded complete data and results.

Keyes says the effort was, at times, frantic. He and the ICTR team worked directly with dozens of researchers to bring Johns Hopkins into compliance.

“I’m a project manager,” Keyes says. “We approached it as a really big project. Breaking big projects into pieces helped us get this done quickly and, more important, completely.”