Applying Complex Innovative Clinical Trial Designs to Orphan Drug Development
The design and development of orphan drugs, designed for rare diseases, are uniquely challenged as limited patient populations available for clinical trials. While more traditional designs may suffice in normal scenarios, there is a need for more complex innovative clinical trial designs (CIDs). CIDs design efficiently around advanced statistical methods and adaptive approaches to reduce trial timelines while maximizing drug safety for the few patients involved. This blog thus investigates how certain elements and strategic considerations tied to CIDs may be applied for orphan drugs.
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