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"externally controlled single-arm registration trial design"
"Externally controlled single-arm registration trial designs are typically used when there are compelling reasons to believe that the investigational treatment is highly effective, and conducting a randomized control trial with a concurrent control group is not feasible or ethical. However, these designs require rigorous methodology and careful consideration of historical data to ensure that the results are reliable and meaningful."
Searching with CGPT"externally controlled single-arm...
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