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OPINION
Year : 2019  |  Volume : 10  |  Issue : 2  |  Page : 51-56

Conducting real-world evidence studies in India


Consultant – Clinical Research and Development, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Arun Bhatt
303-4, Dheeraj Valley 3/C, Mohan Gokhale Road, Goregaon (East), Mumbai - 400 063, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_8_19

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Real-world data (RWD) are data relating to patients' health status and/or the delivery of health care routinely collected from a variety of sources. Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can provide information on diverse areas, for example, natural history and course of disease, effectiveness studies, outcome research, and safety surveillance. India has unique opportunity of conducting RWE studies in several interesting areas, for example, natural history of communicable and noncommunicable diseases and rare disease and Health Economics and Outcomes Research in public versus private hospitals. However, utility of RWE is challenged by diversity of information, large data sets of uncertain quality, and methodological rigor. For India, there are additional challenges in conducting RWE studies – Indian clinical practice pattern and physicians' interest in RWE studies. It is recommended that RWE studies in India should focus on health management issues of relevance to the country India and should be well planned to generate high-quality data.


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