Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts?

By Celeste A. Elash, YPrime

Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome (PRO) data in clinical trials.¹ In the early 2000s, the shift to ePRO precipitated an unexpected challenge with the release of new guidance and best practice documents. These key industry publications emphasized the need for ensuring the measurement properties of an instrument originally validated for paper-based data collection are not undermined when migrating it to an electronic mode of administration. Since then, the industry has relied on time-consuming and expensive mode equivalence testing but is now considering the process of “expert screen review” as a more efficient and less expensive alternative.