In the mid-1990s, more than a decade after Johns Hopkins opened one of the world’s first neuroscience critical care units (NCCUs), neurologist Dan Hanley and his collaborators were publishing innovative research on new ways to treat intraventricular hemorrhage. But to truly change medical practice — the goal of most clinical trials — the researchers would need to move from single-site trials based at Johns Hopkins’ NCCU to multisite trials conducted at hospitals across the country, or even around the world. Toward that end, the team applied for a grant to run the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR-IVH) trial.

The process was not smooth, Hanley remembers: There were multiple roadblocks along the way, including suddenly losing access to their investigational drug and having to resubmit their grant application several times. In the end, they were rewarded not just with funding for their hard-earned efforts, but something else just as valuable — education on the process of developing and running multisite trials.

Over the next couple of years, Hanley and colleague Karen Lane spun this learning into an enterprise helping researchers at Johns Hopkins and elsewhere run their own multicenter trials: the BIOS Clinical Trials Coordinating Center (CTCC).

“With the expertise we gained, we realized there were tools that could be developed that actually helped support operations to make trials go faster, smoother and with fewer roadblocks along the way,” says Lane, who now serves as BIOS CTCC’s deputy director.

At first, Hanley explains, he, Lane and his collaborators used this knowledge to develop their own multisite trials on brain injury. But soon after their own success with the CLEAR-IVH trial, colleagues across Johns Hopkins approached BIOS CTCC for advice about moving their own single-site trials to a multisite design. Eventually, the center helped investigators develop and run trials for a range of disease areas, including muscular dystrophy, sickle cell disease, infectious disease, cardiovascular disease and neuromuscular disorders.

In 2015, their collective and hard-won expertise landed BIOS CTCC a $25 million grant from the National Center for Advancing Translational Sciences to position it as a Trial Innovation Center. With this boost, the team began offering a range of services — including study design, project and data management, statistical support and training — for the National Institutes of Health Clinical and Translational Science Awards Program, a federal initiative that supports a national network of more than 60 medical institutions in speeding the translation of research discoveries into improved patient care. The grant also helped BIOS CTCC develop and then test the effects of several innovations in clinical trial management, Hanley said.

One was an accelerated startup. By applying lean manufacturing principles to clinical trial design, Lane explains, researchers are able to take startup time from an average of 270 days to 90, giving them significantly more time to spend on recruitment. Another was gamifying different aspects of the clinical trial process for investigators, with an element of competition to help them reach milestones on time or even early, and giving rewards and recognition for meeting specific goals.

Now 25 years old, BIOS CTCC has helped to move numerous trials expeditiously from concept to completion, generating findings that will change medical practice and ultimately improve human health. Two prominent examples, Hanley says, are multicenter trials led by Johns Hopkins that began in 2020 and focused on using convalescent plasma to prevent infection or to prevent hospitalization after COVID-19 exposure.

With the heavy toll on human health and life in the early days of the pandemic, Hanley remembers, researchers across the country were under enormous pressure to quickly develop viable methods to prevent COVID-19 infection and to limit morbidity and mortality. Using the protocols that BIOS CTCC had developed over the years to speed the pace of multisite trials, the center’s experts helped Johns Hopkins researchers rapidly design the two trials, launch them at hospitals across the country, gather results and submit their findings to journals.

These trials moved from site selection to peer review for publication in less than 24 months, Lane says, with results of the treatment study published in the New England Journal of Medicine in early 2022. The next year, the same study was named a Top 10 2023 Clinical Research Achievement Awardee by the Clinical Research Forum, a designation that honors studies that demonstrate a commitment to excellence and innovation in clinical research.

“These two trials are outstanding examples of investigators using the tools we developed to bring multisite studies from concept to completion in an extremely rapid fashion,” Lane says.

Current studies run by BIOS CTCC include:

• A trial testing an oral anticoagulation therapy for atrial fibrillation guided by a smartwatch
• A trial evaluating possible changes in cognition after patients with Alzheimer’s disease are prescribed a sleep aid
• A trial comparing the drug hydroxyurea to a placebo in children with sickle cell disease

“Making big changes in how we deliver medicine and health care is our ultimate goal, and to get there, we need to have more trials, better trials and faster trials. That’s what drives us,” Hanley says.

Contact the BIOS CTCC at 410-361-7999.