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

ABSTRACT: As real-world data (RWD) becomes more available and the methodology for handling RWD evolves, the use of RWD in drug development and drug approval is drawing interest. One of the ways RWD can be applied to a clinical trial is using an external control, a cohort of patients established separately serving as a control group for the clinical trial's treatment group. Although external controls have the possibility of bias as a result of differences in baseline characteristics between the external control and experimental groups, selecting an appropriate data source and ensuring comparability through proper handling of the data can increase the utility of external controls, raising the efficiency of drug development. This article discusses several topics relevant to using external controls in c

SUBMITTER: Kim TE 

PROVIDER: S-EPMC9532857 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature