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Activity Number:
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48
- Academics Industry Perspectives on Cancer Data Innovations: Simultaneous Inference, Inconsistency, and Clinical Response
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Type:
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Topic-Contributed
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Date/Time:
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Sunday, August 8, 2021 : 3:30 PM to 5:20 PM
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Sponsor:
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Biometrics Section
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Abstract #317236
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Title:
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Estimating Clinical Response Rate in Biomarker-Guided Oncology Studies Using Preclinical Data
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Author(s):
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Shibing Deng* and Feng Liu and Jadwiga Bienkowska
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Companies:
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Pfizer, Inc and Pfizer, Inc and Pfizer. Inc
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Keywords:
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Biomarker;
Oncology;
Translational
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Abstract:
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Prospective patient selection using potential predictive biomarker is becoming an important decision in the design of oncology clinical trials. In early oncology development, there is very limited information about biomarker’s association with clinical response at the study planning stage. It is very challenging to predict the impact of patient selection with a biomarker on the response outcome of the clinical trial and make decision on whether to use a biomarker in the study to enroll patients. In this presentation, we propose a method to incorporate preclinical biomarker data, assay performance and biomarker prevalence in targeted population to estimate the response rate in biomarker selected and unselected populations, and quantify the underlying variabilities associated with the estimate. We applied the method to several biomarker enriched trials and demonstrated that it was able to correctly estimate the real-world clinical trial outcomes. This method can be used by the clinical study team to help make decision on biomarker guided patient selection during study design.
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Authors who are presenting talks have a * after their name.
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