The US Food and Drug Administration (FDA) has issued a new draft guidance regarding the use of external control arms in clinical trials. The guidance comes as external controls are increasingly implemented in trials, owing to the growing acceptance or real-world evidence (RWE) in regulatory decision-making. This is especially the case in trials diseases that have small populations or those where holding back treatment would be potentially unethical.
According to the draft guidance, “Although unmeasured confounding, lack of blinding, and other sources of bias cannot be eliminated in externally controlled trials, an assessment of the extent of confounding and bias, along with analytic methods to reduce the impact of such bias, are critically important in the conduct of such trials.”
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(Source: Endpoints News, February 2nd, 2023)