Talking to patients in a cursory way simply to check off that box is not what true patient-centric clinical trials are all about, according to John Whyte, Director of Professional Affairs and Stakeholder Engagement at the Food and Drug Administration (FDA). The agency wants to see evidence that the trial designers know exactly what they are measuring, how it set up its endpoints, and that participants have been involved throughout the process, not just at the outset.
At the same time, Whyte acknowledged that Clinical Research Coordinators and others involved in trials are sometimes wary of talking to patients in any kind of depth. The reason? Fear of legal repercussions or giving away proprietary information about a drug. The misunderstanding? Trial practitioners often don’t understand that the agency is most concerned about communications regarding off label promotion. “In fact, FDA wants to encourage real, substantive patient interactions about the how and why of a clinical trial,” he noted.
“Help patients understand how a drug is approved,” Whyte told attendees of the 3rd Annual Patient-Centric Clinical Trials 2016 conference presented by eyeforpharma in Philadelphia Oct. 11. “Patients are the experts in their own disease and they want to be involved,” added Whyte.
However, despite some requests from industry, Whyte advised attendees not to expect a new FDA guidance on patient interactions. “FDA doesn’t need to provide a safe harbor [for subject communications] because there is no prohibition,” Whyte stressed.
Other speakers echoed some of Whyte’s comments. Challenging trial practitioners to do a better job of developing clear endpoints and effectively communicating them to patients, Jamie Roberts, Senior Clinical Project Manager with the Clinical Trials Transformation Initiative (CTTI), also empathized that it was not a simple question of endpoint quantity.
Ironically, many trials already have too many endpoints and that is part of the reason that an estimated 70% of trials require amendments at some point during the process, she said. Does the endpoint demonstrate clear value to the patient? If not, it might be a good idea to really think that endpoint through, speakers emphasized.
Finally, if you are worried about giving away proprietary information as part of your discussions with patients, Roberts suggested asking them to sign non-disclosure agreements (NDAs). “They’ll respect that,” she said.
Author: Michael Causey, ACRP Editor-In-Chief