Clinical Trials Commons^™

Natural Lead-In Approaches To Response-Adaptive Allocation In Clinical Trials, Erin E. Donahue

Theses and Dissertations

Response-adaptive (RA) allocation designs can be implemented in clinical trials to skew the allocation of incoming subjects toward the better performing treatment group based on the previously accrued subjects' responses. These designs alleviate potential ethical concerns of equally allocating subjects in a trial when one treatment arm is inferior. The RA design can be generalized to include covariate information in the covariate-adjusted response-adaptive (CARA) design, which aims to maximize treatment successes conditional on a set of patient characteristics. While RA and CARA designs can improve the treatment of patients, they have unstable estimators and increased variability in early stages of …

Safety Constraint Optimization Of Combination Drug Therapy In Hypertension Clinical Trials, Victor Chukwu

College of Graduate Studies: Theses & Dissertations

In Clinical Practice, combination drug therapy has become common in treating many disease conditions. The purpose of these combinations is often to ensure optimal efficacy and to reduce adverse effects that may arise from monotherapy. Clinical trials have also been conducted to ensure efficacy and safety of these combinations before they are introduced into the market. However, adverse effects still occur with combination therapies. The objective of this study is to (1) To determine a region of optimum doses of Drug A and Drug B in combination while focusing on efficacy alone (2) To determine a region of optimum doses …

Simulations Of A New Response-Adaptive Biased Coin Design, Aleksandra Stein

Department of Statistics: Dissertations, Theses, and Student Research

Modern medical experiments accrue and treat patients--hence obtain treatment response data--throughout a trial. Designs which prospectively plan to modify patient allocation by leveraging accumulating data are response-adaptive randomization (RAR) designs. Many such designs attempt to balance the desire to bias assignment proportions towards a treatment which is performing better against the need to maintain randomization in the face of continued equipoise.

This dissertation consists of simulated investigations into frequentist and ethical properties of an new RAR biased coin design. Chapter 2 proposes a new adaptive design for phase III clinical trials, a modification of the 2001 Bandyopadhyay and Biswas biased …