Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpretation of measurements, when they require the application of complex endpoint assessments, or when a study cannot be blinded.
In this guide, you’ll learn about a process to make such interpretation more robust, and how a verification of (subjective) assessments by an independent panel of experts is frequently utilized.