There’s a moment after you shake a Magic 8 ball where its “prediction” hasn’t quite come into focus yet on the screen. Whether or not you are a true believe in hybrid and fully decentralized clinical trials (DCTs), that fuzzy image concept is relevant for many stakeholders when it comes to discussing their long-range cost implications.
Calling it a “beginning” in the journey to data-driven clarity, Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, senior vice president for scientific and clinical affairs at ICON plc, notes a new study from the Tufts Center for the Study of Drug Development with data from Medable offers positive signs DCTs and hybrids will ultimately save money for clinical trial practitioners. “We’re still learning, and we need more studies and data, but I absolutely believe there will be associated cost savings” when leveraging DCT and hybrid tools and tactics, he says.
“I think the Tufts survey results are encouraging,” says Ingrid Oakley-Girvan, PhD, MPH, senior vice president of research and strategy at Medable. Regardless, she stressed that DCTs and hybrids aren’t right for all trial situations, and should only be used when they can more effectively “take the trial to patients and help them participate with greater ease.”
Preferring the term “agile clinical trial” over DCT or hybrid, Elisa Cascade, chief product officer at Science 37 and a member of ACRP’s Association Board of Trustees, is a firm believer in the benefits of using the tools and tactics to widen patient participation, improve diversity and retention, and save money and time along the way. The company’s internal data suggest agile approaches have made trials 15 times faster and three times more diverse, Cascade says.
“We’re actively collecting data now, but the [early] data show a huge [positive] impact on throughput in trials improving recruitment, retention, and diversity,” Cascade says. “Studies should be about patient choice,” she adds. “Some patients will want to be able to see their doctor or nurse onsite, and agile clinical trials provide the flexibility to meet patients wherever they are.”
“The nifty thing about DCT and hybrid is you can use components of DCT” to match with different types of studies and scenarios, Oakley-Girvan says. “It’s an ala carte menu, and a fit to purpose” approach. “There will always be studies that require some brick-and-mortar component,” she adds.
The Tufts study shows that, on average, DCT or hybrid usage can mean fewer protocol amendments. “Not for every study, but certainly on average,” says Oakley-Girvan.
A precision medicine company working with Medable, focused on the development of new therapies for age-related macular degeneration, was trying to figure out how to conduct a study that was very expensive because it required more than 100 physical sites to serve individuals with this rare disease. The company needed to quickly and cost-effectively screen 11,000 patients to determine eligibility and to optimize the site locations.
Deploying Medable eConsent, eRecruitment, and direct-to-patient biosample shipments, the ensuing decentralized workflow included remote patient access that reduced costs (estimated savings of $20 million by reducing to 25 sites) and, ultimately, time to treatment, according to Medable.
Author: Michael Causey