Endpoints are the cornerstone of clinical trial design and are the critical elements for evaluating the success of a clinical study. Endpoints are communicated in clinical protocols, study reports, study registration and result posting sites, as well as publications. It is, therefore, important that endpoints are presented consistently, correctly, and completely. The FDAAA Final Rule expectations of describing endpoints in specific terms provides a way to keep this consistency across all documents.
Keywords: clinical study reports; endpoints; journal articles; outcome measures; outcome variables; protocols.