Fasten your seat belts, because the clinical trial industry is about to go on a wild ride to a brave new world where it’s no longer business as usual.
Peering into his crystal ball, healthcare visionary Kenneth Getz painted a picture of a not-so-distant future clinical trial landscape in some ways unrecognizable from the way we’ve done things to date. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. He is also the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he conducts research programs on drug development management strategies and tactics, outsourcing, global investigative site and patient recruitment practices and policies.
Driven by new technologies, an avalanche of patient data, and new economic pressures, among several other factors, the clinical trial of the future is liable to be more “flexible, adaptative, pragmatic” and collaborative in design, he told a packed auditorium at ACRP 2019 in Nashville yesterday.
“All of this will require a culture change, a different way of thinking,” he said. “It speaks to the huge need to demonstrate that the professionals supporting this enterprise have the competency and training in whatever environment we operate to support the factors that would support compliance and integrity” in clinical trial conduct, Getz noted.
Some of his predictions are already visible on the horizon. For example, process is no longer king, Getz said. “You will continue to see us moving away from the sequential process that has defined clinical trial activity and more to processes that are data oriented,” he said. Look for clinical trial design approaches that are more data-oriented and “optimized for convenience, open innovation and transparency.”
Quality management using risk-based assessment as a favored practice will only accelerate in the next few years, too, Getz predicted.
Trial infrastructure is going to get more portable, with an emphasis on mobile solutions, he said. Expect to see “hybrid approaches and clinical trials embedded within larger settings,” Getz added.
Getz spoke of a future demand for “roving, flexible clinical research professionals who could operate within a health system or operate externally from a traditionally investigative site.” The rise of hybrid and decentralized trials may be on the horizon, and with it the ability to “accommodate a number of different approaches simultaneously,” he said.
That’s going to “dictate more flexible models where you can literally put personnel directly on a study when we see that a patient or group of patients are ultimately best able to participate. All professionals will need to have some flexibility in order to be part of this new environment,” Getz emphasized.
Author: Michael Causey