title: Real world evidence: An Indian perspective.
abstract: Randomized controlled trials (RCTs) are the gold standard for measuring the safety and efficacy of drugs. However, they are being challenged by payers and health care providers since they are looking for real world evidence (RWE) to validate whether the new intervention provides similar safety and efficacy as reported in RCT data. RWE uses real world data (RWD) to generate insight, foresight, and explorative findings on diseases, products, and patient populations. There are varied sources of RWD such as administrative data, large pragmatic trials, registries, electronic health records, and health surveys. RWE approaches are increasingly becoming the normal practice in developed countries to bring a product to the healthcare market and to ensure its significance in clinical practice. The Indian healthcare sector is growing at a brisk pace and is grasping up with the principles of health economics and outcome research, thereby exhibiting the value of real-world insights in healthcare decision. India has taken a step toward RWE by developing a framework to assist health care providers in harmonizing RWD for economic, clinical, and humanistic outcome.
authors.affiliation: MarksMan Healthcare Solutions LLP, Kopar Khairane, Navi Mumbai, Maharashtra, India.
authors.forename: Amit
authors.initials: A
authors.lastname: Dang
authors.affiliation: Department of Pharmacology, Velammal Medical College Hospital and Research Institute, Madurai, Tamil Nadu, India.
authors.forename: B N
authors.initials: BN
authors.lastname: Vallish
keywords: Clinical outcome; health economics; health technology assessment; humanistic outcome; real world data; real world evidence