Real-World Evidence and Post-Marketing Surveillance: Why They Are Growing Rapidly

A drug passes its clinical trial. It receives regulatory approval. And then — the real world takes over.

Clinical trials are designed with precision. Patient populations are carefully selected. Conditions are tightly controlled. Protocols are strictly defined. They answer one question rigorously: does this drug work under ideal circumstances? But what happens when that same medicine is prescribed to a 65-year-old with multiple comorbidities and a complex existing medication regimen? That is the question Real-World Evidence is built to answer.

WHAT IS REAL-WORLD EVIDENCE: Real-World Evidence (RWE) is clinical evidence derived from data collected outside the controlled setting of a randomised clinical trial. Sources include electronic health records (EHRs), administrative insurance claims, disease registries, patient-reported outcome data, and connected health device outputs. RWE addresses the questions trials often cannot: How does this therapy perform across diverse, unselected patient populations? What long-term safety signals emerge over years of routine use?

POST-MARKETING SURVEILLANCE AND PHARMACOVIGILANCE: Safety monitoring doesn’t ease after approval — it intensifies. Post-Marketing Surveillance (PMS) is the systematic, ongoing evaluation of a product’s safety and effectiveness in routine clinical use. It encompasses spontaneous adverse event reporting, Periodic Benefit-Risk Evaluation Reports (PBRERs — previously referred to as PSURs), and Risk Management Plans (RMPs) submitted to regulatory authorities.

In India, the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission under the Ministry of Health and Family Welfare, collects and evaluates adverse drug reaction reports from healthcare institutions nationwide — positioning India as an increasingly significant node in the global pharmacovigilance network.

WHY THIS FIELD IS GROWING RAPIDLY: Regulatory agencies — including the U.S. FDA, the European Medicines Agency (EMA), and CDSCO — are progressively incorporating RWE into regulatory decision-making for label expansions, new indication evaluations, and post-approval commitments. This shift has created substantial demand for professionals who understand pharmacoepidemiology, safety database platforms, and applicable regulatory frameworks.

For healthcare graduates, RWE and PMS represent one of the clearest convergence points of clinical knowledge, data literacy, and regulatory awareness — a future-oriented career space with a growing global talent gap.

References

1. U.S. Food and Drug Administration (FDA). Considerations for the Design, Conduct, and Analysis of Observational Studies Using Real-World Data. FDA; 2023.
2. Indian Pharmacopoeia Commission (IPC). Pharmacovigilance Programme of India (PvPI). Ministry of Health and Family Welfare, Government of India; 2024.
3. European Medicines Agency (EMA). Regulatory Science Strategy to 2025: Real-World Evidence Framework. EMA; 2023.
4. Makady A, de Boer A, Hillege H, Klungel O, Goettsch W, on behalf of GetReal Work Package 1. What is real-world data? Value Health. 2017;20(3):520–532.