Events Calendar

30 Sep
Biostatistics Seminar: Jared Lunceford (Merck) Statistical Bridging Studies for Companion Diagnostic Development
Event Type

Lectures, Symposia, Etc.

Topic

Research

Target Audience

Faculty, Graduate Students

University Unit
Department of Biostatistics
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Biostatistics Seminar: Jared Lunceford (Merck) Statistical Bridging Studies for Companion Diagnostic Development

Jared K. Lunceford, Ph.D.

Distinguished Scientist
Merck Research Laboratories
Early Development Statistics

Abstract: Early or late phase clinical trials that aim to enroll a biomarker selected patient population are often initiated using a clinical trial assay (CTA) which may differ in assay components compared to the final companion diagnostic assay (CDx), potentially necessitating further clinical analysis to bridge study conclusions to results based on the CDx.  There may be substantial missing data due to the retrospective nature of CDx sample testing.  Key elements of the ideas behind bridging will be reviewed using a case study conducted for a randomized trial of pembrolizumab in second line metastatic non-small cell lung cancer.  Emphasis is on methods aimed at constructing an imputation model to (1) confirm the robustness of clinical trial conclusions via the Bayesian posterior predictive distribution of the study’s intention-to-treat testing results and (2) conduct sensitivity analysis for estimands of the intention-to-diagnose population, while capturing all sources of variability.

Dial-In Information

Please email Jiebiao Wang (jbwang at pitt.edu) for Zoom info.

Thursday, September 30 at 3:30 p.m. to 4:30 p.m.

Virtual Event

Biostatistics Seminar: Jared Lunceford (Merck) Statistical Bridging Studies for Companion Diagnostic Development

Jared K. Lunceford, Ph.D.

Distinguished Scientist
Merck Research Laboratories
Early Development Statistics

Abstract: Early or late phase clinical trials that aim to enroll a biomarker selected patient population are often initiated using a clinical trial assay (CTA) which may differ in assay components compared to the final companion diagnostic assay (CDx), potentially necessitating further clinical analysis to bridge study conclusions to results based on the CDx.  There may be substantial missing data due to the retrospective nature of CDx sample testing.  Key elements of the ideas behind bridging will be reviewed using a case study conducted for a randomized trial of pembrolizumab in second line metastatic non-small cell lung cancer.  Emphasis is on methods aimed at constructing an imputation model to (1) confirm the robustness of clinical trial conclusions via the Bayesian posterior predictive distribution of the study’s intention-to-treat testing results and (2) conduct sensitivity analysis for estimands of the intention-to-diagnose population, while capturing all sources of variability.

Dial-In Information

Please email Jiebiao Wang (jbwang at pitt.edu) for Zoom info.

Thursday, September 30 at 3:30 p.m. to 4:30 p.m.

Virtual Event

Topic

Research

Target Audience

Faculty, Graduate Students

University Unit
Department of Biostatistics

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