Real World Data (RWD)

USA: FDA’s Framework for Real-World Evidence Program – Data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources (as per Framework for FDA’s Real-World Evidence Program – Glossary)

China: Key Considerations in Using Real-World Evidence to Support Drug Development – Data collected for a patient’s health status and/or derived from various routine medical processes that can be analyzed to potentially form real-world evidence (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)

EU: imi GetReal Glossary – An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not collected in the context of highly-controlled RCT’s. Instead, RWD can either be primary research data collected in a manner which reflects how interventions would be used in routine clinical practice or secondary research data derived from routinely collected data. Data collected include, but are not limited to, clinical and economic outcomes, patient-reported outcomes (PRO) and health-related quality of life (HRQoL). RWD can be obtained from many sources including patient registries, electronic medical records, and claims databases. (See also “randomised controlled clinical trial”, “real-world evidence” and “real-world study”)(Adapted from Garrisson, 2007 and GetReal, 2016) [Source: imi GetReal Glossary – 25 Oct 2016 Adapted from Garrisson, 2007]* * Garrison et al. (2007). Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report. Value in Health 10:5, 2007

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