Open the patient-physician conversation on clinical trials

The ongoing fight against COVID-19 has highlighted significant health care delivery disparities. Proximity to both academic research centers and provider clusters has become an even more important determinant for participation in clinical trials and overall average health of families. 

Recent controversies over these vital questions of health equity in clinical research have missed a critical point: Political incentives can overcome barriers based on geography and proximity to ensure robust and diverse patient participation in clinical trials. The time has come to construct policies that bring these goals into fruition through open physician-patient conversations and an expansion of decentralized clinical trials.

In “The Political Determinants of Health,” Daniel Dawes, director of the Satcher Health Leadership Institute at Morehouse School of Medicine, makes the case that political determinants such as the scope of legislation and the breadth of regulation often drive the success or failure of health, redirecting the current and frequent conversation in health policy circles that social determinants drive health outcomes. Biopharma research stakeholders took significant steps, even well before the pandemic, to make certain that clinical trials reflect the broader population. Recent COVID-19 trials, in particular, have shown it is achievable, yet there is a long way to go to ensure that diversity in clinical trials becomes the norm. 

Health policy experts face a chicken or the egg problem. On the one hand, patient participation is inextricably tied to the speed and success of a trial. On the other hand, the single greatest source of delay is finding and enrolling patients, a challenge that only grows as new, sophisticated therapies become more targeted to the individual.

While this challenge has many causes, several studies point to a missed opportunity at the point-of-care level. The National Center for Biotechnology Innovation, in 2017, found that fewer than 5 percent of eligible cancer patients are enrolled in clinical trials even though 70 percent are willing to participate if asked. Even more disturbing, 45 percent of patients surveyed reported that clinical trials were rarely considered as an option when discussing treatments or medications with their physician. 

We should combat the myth that patients are unwilling or uninterested in trials — there is strong evidence that their providers simply never started the necessary conversation. When trials are discussed, they are quite popular. A Research! America poll in partnership with Zogby is most striking, indicating that 81 percent of Americans would be likely to participate in clinical trials if they were recommended by their doctor.  The same poll found 85 percent of Americans believe that discussion of clinical trials should be part of standard care. 

Physicians face significant barriers to highlighting clinical trials. Providers without close ties to academic research centers face the challenge of learning about trials as quickly as some of their peers. But there is also no present incentive for providers to spend time talking with their patients about those options.

There is a solution. The Centers for Medicare and Medicaid Services (CMS) should offer incentives to providers to inform their patients of the availability of a clinical trial when appropriate. Legislative action instructing CMS to develop a reimbursement code for such counseling for providers would go a long way in narrowing the access gaps to clinical trials. Physicians in under-resourced communities would be given a much-needed incentive to take valuable patient time to talk about the clinical trials that might be available, even if the trial sites are several hours away.

Reimbursement for informing patients about clinical trials, however, should be supplemented by increased support for decentralized trials. This will require robust support from the Food and Drug Administration. Historically, trials have been centered around trial sites, locations where patients receive a new product that is evaluated for safety and efficacy. These traditional trials require that the patient travel, creating an often-burdensome requirement for participants. Decentralization turns these dynamics on their head, making use of new approaches through innovative mobile technologies. 

Over the past year and a half, clinical research was the single most significant enterprise in slowing the pandemic’s global grip on life and death. Legislative action to encourage patient participation in clinical research along with regulatory support for a new era of decentralized trials will together enhance a research ecosystem that narrows the access gap and, ultimately, incentivizes patient conversations about hopeful innovation.

Andrew Barnhill is head of policy for IQVIA, the world’s largest clinical research organization. He is also adjunct assistant professor of the practice of public service at New York University’s Wagner School, where he teaches health policy. He may be reached at andrew.barnhill@nyu.edu and on Twitter @ATBarnhill.