Abstract:
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Simon’s two-stage design has been one of most used trial design in oncology proof of concept studies with binary endpoints. Traditional Simon’s two-stage is for one endpoint only. But most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics, especially in the early phase of drug development process. As the number of endpoints analyzed in a single trial increases, the likelihood of making false conclusions about a drug’s effects with respect to one or more of those endpoints becomes a concern if there is not appropriate adjustment for multiplicity. In this research, we extend the traditional Simon’s two-stage design to two-stage design with dual endpoints, and develop a SAS program to estimate sample size with prespecified Type 1 and Type 2 errors. The methods and codes can be easily modified to two-stage design with co-primary endpoints
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