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External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

 
• By Sue Sutter

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

External or internal? External

Use of a synthetic control arm drawn from historical clinical trial data could provide better information about a new investigational agent’s safety and efficacy than single-arm studies and allow sponsors to conduct randomized trials that are smaller, or with more patients assigned to the investigational drug.

However, such an approach should not be considered a replacement for randomized, controlled trials when they are feasible to do,...

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