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.
Please email nanderson@drexel.edu
for Zoom information.
Contact Information
Nancy Colon-Anderson
nanderson@drexel.edu