The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design

By Jill Johnston and Sara Ray

Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong--or not doing it at all--can undermine a trial.