Listen First, Develop Protocols Second: A How-To Guide For Implementing Patient Voice In Clinical Trial Design

Patients with a disease are going to be the most knowledgeable about how the illness affects their lives, including symptoms and quality of life as well as everyday activities like working, using resources, and socializing. This living experience should inform how a clinical trial tests treatment for that disease. It seems simple, but somehow, it’s not. Despite having insight into how a new drug or product should be tested, the clinical research industry continues to focus on trial protocols, clinical outcome assessments (COAs), biomarkers, and other research tools that aren’t actually patient-centric.

As a result, the constant remaining question is one of practicality: how can researchers get patient input early enough in the trial design process so that the protocol reflects real-world patient needs? Follow these steps to gather and implement patient voice in your next protocol design.