Real-World Evidence
Clinical evidence generated from real-world data sources such as electronic health records, insurance claims, patient registries, and observational studies, as opposed to controlled clinical trials. Real-world evidence increasingly supports regulatory decisions and clinical guidelines for peptide drugs.
Technical Context
RWE sources include: electronic health records (longitudinal patient data), insurance claims databases (treatment patterns, outcomes, costs), patient registries (disease-specific or drug-specific), personal health records and wearables, and social media/patient forums. Regulatory use: FDA Framework for RWE (2018) outlines how RWD can support new indications, label changes, and post-marketing requirements. The 21st Century Cures Act encourages FDA to use RWE. For peptide drugs, RWE has been used to: assess real-world GLP-1 RA effectiveness and adherence (often lower than trial efficacy), investigate post-marketing safety signals, compare treatments not directly compared in head-to-head trials (indirect treatment comparisons), and study outcomes in populations underrepresented in trials (elderly, paediatric, diverse ethnicities).