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October 26, 2022

As you read about the ‘adaptive design’ type of clinical study do you believe this study design represents a new ‘gold standard’ for supporting proof of safety and efficacy for new biopharmaceutical products and high risk medical devices

As you read about the ‘adaptive design’ type of clinical study do you believe this study design represents a new ‘gold standard’ for supporting proof of safety and efficacy for new biopharmaceutical products and high risk medical devices? Should this type of study design be utilized in all investigations to support marketing approval applications to all global regulatory agencies as opposed to an RCT? Are there exceptions? Why or why not?

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