A number of changes could affect the future of clinical trials, including the increased involvement of health-care providers, said Thomas Pike, the former CEO of Quintiles, during a talk here last week.
Pike spoke as part of the Dean's Lecture Series, which brings to campus thought leaders in science, medicine and business.
Health-care reforms are needed, said Lloyd Minor, MD, dean of the medical school, in his introduction of Pike. "We need to rethink how we collect, secure, analyze and share our data. Fortunately, the opportunities surrounding us have never been better," Minor said. "Accomplishing this mission means embracing real-world evidence outside the clinical trial space."
To that end, Stanford is one of the leaders of Project Baseline, a four-year project that will track the health of 10,000 participants. "This initiative will give us a view of health that is more of a feature film than it is a snapshot in time, not only what makes people sick, but also what helps keep us healthy," Minor said. "It seeks to disrupt the status quo."
Similarly, clinical research will increasingly spill out of the confined framework of formal trials, Pike told the audience. For example, rather than simply collecting data during a defined period before a product is approved by the Food and Drug Administration, clinicians could continue to monitor the drug's efficacy after approval when it is exposed to a host of real-world conditions. Currently, data is gathered about the safety and efficacy of drugs and devices during a formal clinical trial, which is often administered by an independent company. Following approval, little data is collected.
Pike said regulatory changes should also be made so that patients are able to get medications as soon as their efficacy and safety is initially indicated. "If you have cancer today and there is the potential of an immunotherapy treatment coming along, it is just not right if you don't have access to that," Pike pointed out.
Increasing the involvement of providers in clinical trials may also help distribute some of the revenue generated by the trials toward providers and hospitals, many of which are cash-strapped, Pike told lecture attendees. Participating in clinical trials could also improve the ability of providers to attract and retain patients and could help them keep their skills and knowledge fresh, he said.
Becoming involved in trials may be difficult for a small practice or hospital, Pike admitted. For example, a large organization well-rehearsed in trial administration can gain efficiencies of scale. In addition, increasing the involvement of health-care providers, who use a variety of record systems, could make data sharing and comparing even more challenging.
Nonetheless, Pike is optimistic.
"There's a huge opportunity for providers and academic institutions to play a role and fundamentally change research, but we have some pretty significant changes we have to get through," he concluded.
Previously: Cancer clinical trials: Why I chose to participate, but so many others don't, Cancer clinical trials: Stanford strives to enroll more diverse participants and Should patients pay their way into clinical trials?
Photo by Paul Keitz