Compliant Cocreation Key For Digital Innovation

By Ilyssa Levins

FDA commissioner Scott Gottlieb, MD, says he’s focused on fostering innovation at the intersection of medicine and digital health technology. That fact, coupled with the agency’s patient-focused drug development program (integrating the “patient voice”), nurture a fertile environment for digital innovation.

"In R&D, digital tools can optimize the development of targeted therapies, speed up clinical trial enrollment, and convert trials into adaptive studies that provide patient feedback at many points along the research continuum,” says author, speaker, and consultant, Françoise Simon, Ph.D., professor emerita, Columbia University, and senior faculty member at Mount Sinai School of Medicine. “At the commercial end, these tools may allow a deeper integration of the customer voice, from product development to post-launch communications. The tools also can help to collect real-world evidence and integrate patient-reported outcomes into clinical data to prove a product’s value.”