An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

Conclusion:
While no one size fits all, the need to include an IRC depends on the subjectivity of the primary endpoint, the therapeutic area concerned, the clinical trial design, the need to assess reliability of marginal positive events, or if a critical assessment is required for adverse event accuracy.

Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Krumholz-Bahner, S., Garibbo, M., Getz, K. A., Widler, B. E. Tags: Regulatory Science Source Type: research