Patient Voices Often a Neglected Clinical Trial Resource

James Valentine, Hyman, Phelps, & McNamara, PC

James Valentine, Hyman, Phelps, & McNamara, PC

While we’ve “come a long way” when it comes to actually listening to the patients involved in clinical trials, there’s still a lot more to do, says James Valentine, an attorney with Hyman, Phelps & McNamara, PC.

It wasn’t until the late 1980s, as activists protested a perceived lack of U.S. Food and Drug Administration (FDA) engagement with HIV/AIDS patients, that the tide began to turn, Valentine told attendees of “The Patient’s Assessment of the Patient-Focused Drug Development Meeting Initiative” session at the DIA 2018 Global Annual Meeting today (June 26) in Boston.

These days, the FDA is doing a much better job soliciting patient input and patient voices before, during, and after clinical trials, says Theresa Mullin, FDA’s associate director for strategic initiatives at the Center for Drug Evaluation and Research. She shared some of FDA’s “lessons learned” so far about patients with serious chronic diseases:

  • They are experts on what it’s like to live with their conditions.
  • Their “chief complaints” may not be factored explicitly into drug development plans, including the measures of drug benefits planned to be achieved in trials.
  • They want to be as active as possible in the work to develop and evaluate new treatments.
  • They and their caregivers are able and willing to engage via Internet, social media, and other means.
  • They are not expecting FDA to address all current gaps in patient engagement, but want FDA to provide clear, actionable guidance on what they and others need to do.
  • They are concerned that many patient-centric efforts under way by various organizations may be duplicative and not coordinated.
  • They are willing to participate in clinical trials, but want them designed to make that more feasible, sustainable, and tolerable.

“What we’ve learned may sound obvious,” Mullin says. “But it’s not obvious to people in a scientific-heavy environment.” There’s a danger of disregarding the patient voice and acting is if “people with initials after their names” are the only experts about a given condition, she adds.

FDA hopes to ramp up meetings with patients grappling with various conditions. Earlier this year, it conducted one such meeting with people struggling with opioid use disorder. The agency has set a July 9 date for a session focusing on patients with chronic pain.

Next year, FDA plans to conduct a public workshop to gather experiences and recommendations of patients and caregivers to enhance engagement in clinical trials, Mullin told attendees.

Author: Michael Causey