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.
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