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University of North Florida

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Full-Text Articles in Clinical Trials

Variance Shrinkage In Dunnett-Type Multiple Comparisons With Missing Data, Md Habibullah Jan 2026

Variance Shrinkage In Dunnett-Type Multiple Comparisons With Missing Data, Md Habibullah

UNF Graduate Theses and Dissertations

Dunnett’s procedure is widely used for comparing multiple treatments with a control, but its application becomes challenging in the presence of missing data and multiple com- parisons. An improved Dunnett-type procedure addresses this by using multiple imputation under Rubin’s framework and constructing unified confidence intervals based on a multi- variate t distribution, allowing valid simultaneous inference while controlling the family-wise error rate (FWER). This work further extends the method by incorporating shrinkage-based variance estimation. Specifically, individual group variances are shrunk toward a common value to improve stability. This approach is particularly effective when group variances are similar or moderately different, …


Two-Stage Response-Adaptive Randomization Designs For Multi-Arm Trials With Normal Outcome, Tanjin Tamanna Happy Jan 2026

Two-Stage Response-Adaptive Randomization Designs For Multi-Arm Trials With Normal Outcome, Tanjin Tamanna Happy

UNF Graduate Theses and Dissertations

This study focuses on improving how clinical trials compare new treatments with a standard treatment, when the response is quantitative (normally distributed). In a common two-stage design, several new treatments are first evaluated, and the best-performing one is selected if it appears better than the standard. In the second stage, this selected treatment is compared again with the standard using additional data to confirm its effectiveness. This approach is known to be efficient in terms of accuracy and sample size savings. We extend this design by introducing an adaptive method for assigning patients to treatments in the second stage. Instead …


Ridit-Based Adaptive Allocation In Two-Stage Clinical Trials With Binary Outcomes, Dewan Fahim Jan 2026

Ridit-Based Adaptive Allocation In Two-Stage Clinical Trials With Binary Outcomes, Dewan Fahim

UNF Graduate Theses and Dissertations

This study explores better ways to assign patients to treatments in clinical trials with binary outcomes, such as success or failure. Adaptive methods are used to learn from early results and adjust treatment assignments during the trial, helping more patients receive better performing treatments while maintaining reliable conclusions. We focus on trials comparing multiple treatments using a two-stage design. In the first stage, several treatments are tested to identify the most promising one; in the second stage, that treatment is compared with a control. Unlike traditional equal assignment, we use adaptive allocation in the second stage to make better use …


A Two-Stage Design For Choosing Among Several Normal Treatments In Comparison With A Control: The Case Of Common, Known Variance, Samarasuriyage Sayura Sankalpa Senaratne Jan 2025

A Two-Stage Design For Choosing Among Several Normal Treatments In Comparison With A Control: The Case Of Common, Known Variance, Samarasuriyage Sayura Sankalpa Senaratne

UNF Graduate Theses and Dissertations

A two-stage design is developed for comparing the means of multiple normally distributed treatment groups under a known common variance, with the aim of identifying the treatment with the highest mean while minimizing the expected sample size, a crucial consideration in clinical trials. The proposed methodology integrates elements of both hypothesis testing and selection procedures to achieve greater efficiency and decision-making power. In the initial stage, if no treatment exhibits a mean surpassing a predefined efficacy threshold, the trial is terminated early, conserving resources. If one or more treatments exceed the threshold, the procedure advances to a second stage, where …