Incorporation of real-world data to a clinical trial: use of external controls

다국어 초록 (Multilingual Abstract)

As real-world data (RWD) becomes more available and the methodology for handling RWDevolves, the use of RWD in drug development and drug approval is drawing interest. Oneof the ways RWD can be applied to a clinical trial is using an external control, a cohort ofpatients established separately ser ving as a control group for the clinical trial’s treatmentgroup. Although external controls have the possibility of bias as a result of differences inbaseline characteristics between the external control and experimental groups, selectingan appropriate data source and ensuring comparability through proper handling of the datacan increase the utility of external controls, raising the efficiency of drug development. Thisarticle discusses several topics relevant to using external controls in clinical trials, includingthe definition of external control, the selection of data sources, the strategy ensuringcomparability, current regulator y circumstances, and future directions.

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