Regulatory Compliance in Dermatology and Clinical Trials

Real-World Evidence in India: An Untapped Opportunity for Global Pharmaceutical Companies

Introduction The Pharmaceutical industry has long recognised that randomised controlled trials (RCTs), while the gold standard for establishing efficacy, cannot fully capture how Drugs perform across diverse patient populations in routine clinical practice. Real-world evidence (RWE) — data generated outside traditional randomised controlled trials, including electronic health records, claims databases, disease registries, and prospective observational