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Activity Number: 321
Type: Contributed
Date/Time: Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #310388
Title: Single-Arm Phase IIa Oncology Clinical Trials with Sample Size Adaptation
Author(s): Bob Zhong*+
Companies: Johnson & Johnson
Keywords: Phase IIA trials ; two-stage design ; sample size adaptation
Abstract:

Phase IIA oncology clinical trials are commonly conducted as pilot studies to evaluate efficacy and safety in selected populations of patients with the disease or condition to be treated or prevented. The efficacy objective is to find preliminarily evidence of the effectiveness or ineffectiveness of study treatments measured by response rates. Two-stage designs are often employed and go/no-go decisions will be made at either stage. The sample size of either stage cannot be exactly as planned due to commonly-used per-protocol patient populations in analysis. Therefore, the actual sample size of either stage should be flexible. Additionally, at this early stage of drug development, no one knows the response rates of the experimental treatment. Therefore, total sample size is preferred to be adaptable as well. This manuscript presents designs with these characteristics.


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