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Activity Number:
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278
- Multi-Stage and Seamless Clinical Trials
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Type:
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Contributed
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Date/Time:
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Tuesday, August 9, 2022 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #320773
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Title:
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A 2-In-1 Seamless Phase II/III Design with Graphical Approach in Oncology Drug Development
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Author(s):
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Linda Sun* and Heng Zhou and Wen Li and Calvin Jia
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Companies:
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Merck & Co, Inc. and Merck & Co., Inc. and Pfizer, Inc. and Merck & Co., Inc.
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Keywords:
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Seamless Phase II/III ;
Graphical approach;
Interim analysis;
Oncology;
FWER
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Abstract:
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In oncology drug development, to mitigate the risk of skipping the traditional randomized Phase II proof of concept (POC) study, a 2-in-1 seamless Phase II/III design was proposed by Chen et al (2018). The original 2-in-1 design controls family-wise type I error rate (FWER) for one hypothesis in Phase II part and one hypothesis in Phase III part. However, in practice, for a stand-alone Phase III study usually there are multiple hypotheses with group sequential interim analyses and the multiplicity is controlled by the graphical approach. It is desirable that these features of the Phase III design are retained when 2-in-1 design is considered. The FWER control for such a 2-in-1 design (i.e. one hypothesis in Phase II and multiple hypotheses in Phase III) is yet investigated. This paper provides the analytical conditions under which FWER is controlled with the graphical approach in Phase III part. It also provides the numeric explorations of FWER control for such design with group sequential interim analyses in Phase III. As a result, our work helps lower the hurdle of the application of the 2-in-1 design and pave the way for for its wider application.
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Authors who are presenting talks have a * after their name.
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