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With more and more clinical trials conducted in small sizes because of unmet medical needs or special patient populations such as pediatric patients, enrichment designs have been commonly considered to enhance trial efficiency and the chance of success. At the same time, multiple-trial sponsors who want to develop treatment interventions for the same diseases to save development time and competing resources may consider a master protocol utilizing a common control in platform settings.
Specific enrichment designs, including sequential parallel comparison design (SPCD) and sequential enriched design (SED), that mainly address high placebo response have been proposed and adopted in clinical trials. By taking the advantage of both enrichment designs and multiple studies in one combined trial, we proposed a SPCD-Platform design for small-sized diseases. The presentation will illustrate details of the SPCD-Platform design and its implementation and will also discuss the proper use of the Bayesian approach to borrowing from historical or external trials and its validity.
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