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Abstract:
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Unlike oncology combination study designs, which mainly consider toxicity and safety information, non-oncology combination study designs encompass efficacy, dose, safety, and regulatory considerations. There have been few systematic efforts to study these issues from a statistical point of view. This session illustrates multiple case studies in combination drug development across a variety of non-oncology indications. We also explore adaptive and staged designs that could provide sufficient information about the drug combination in lieu of a full factorial design. Other considerations such as operational complexity will also be discussed.
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