Abstract:
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In clinical research combining existing evidence via a meta-analysis to assess the benefit and risk of an intervention has gained increasing attention. The use of information from other related trials studies could lead to more efficient designs for future studies. In early phase clinical trials, where the key objective is to decide on an optimal dose, historical data used appropriately, could further consolidate the evidence based decision making. Designing a phase 2 oncology clinical trial in the absence of reliable phase 1 data could be a challenge for dose selection and , presumably resulting in a large study which is both time and resource intensive. We show the use of meta-analysis of existing phase I clinical information to enhance the choice of dose and use of historical control data could reduce the sample size needed in randomized phase 2 clinical trial. The challenges and use of existing Bayesian meta-analysis methods are illustrated with application. Details of analysis proposed for a decision making based on the benefit-risk of the investigational treatment relative to control will be presented.
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