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Department of Epidemiology and Biostatistics Dissertation Defense

Wednesday, December 6, 2023

9:00 AM-10:00 AM

From the Department of Epidemiology and Biostatistics at Dornsife, Dominique McDaniel, MS, will present "Principal Stratification and Bayesian Testing in Clinical Trials with Intercurrent Events."

Patients in clinical trials may discontinue their randomized study treatments due to intercurrent events such as adverse side-effects. Accordingly, clinical trials for drug approval must evaluate treatment effects while accounting for intermediate outcomes, to prevent biased inferences that could arise from confounding of latent variables. Existing statistical methodologies for clinical trials such as intention- to – treat typically ignore treatment discontinuation and focus on treatment assignment. Principal Stratification as identified by the ICH E9 (R1) addendum is a strategy to deal with intercurrent events in clinical trials. In this dissertation we (1) introduce a Bayesian testing methodology that can account for the existence of principal strata in clinical trials with intercurrent events, (2) present a Bayesian multiple testing strategy that can account for the existence of principal stratum and multiplicity, and (3) extend methodology for sensitivity analysis to assess assumptions of the use principal stratum methods. The potential utility of these methodologies will be illustrated on simulated clinical trials from a novel data generating model that accounts for multiple intercurrent events under the potential outcomes framework.

Dominique McDaniel is a PhD Candidate in Biostatistics at Drexel University. Dominique completed her undergraduate studies in Mathematics at Cheyney University of Pennsylvania. She also holds a Master of Science degree in Applied Statistics and Mathematical Statistics from West Chester and Purdue University, respectively. Prior to starting her doctoral studies, Dominique worked in the pharmaceutical industry at Eli Lilly & Company in Indianapolis, IN. Dominique's research interests include Bayesian & Spatial Statistics, Clinical- Trial Development, and Causal Inference. In her spare time, Dominique enjoys running, weight training and reading.

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Nancy Colon-Anderson

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Nesbitt Hall 132 and via Zoom


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