Medidata Refines Patient Burden Index to Optimize Clinical Trial Protocols
Medidata, a Dassault Systemes company, has significantly refined its Patient Burden Index (PBI), a data-driven metric designed to quantify the demands placed on participants in clinical trials. This updated index evaluates six core dimensions: pain, invasiveness, harmful exposure, duration, anxiety, and item count, across over 4,000 clinical activities. These activities include modern drug modalities such as CAR-T and gene therapy, as well as digital tools increasingly integrated into trial conduct. The PBI's refinement involved a year-long effort incorporating literature review, cross-functional clinical expertise, and direct input from trial participants. The results are now categorized into clear Low, Medium, and High burden tiers, providing protocol designers with an immediate and interpretable signal for necessary adjustments. This tool aims to help teams design protocols that participants can realistically complete, thereby identifying potential burdens early in the process.