Statistics and Probability Commons^™

Sample Size For Non-Inferiority Tests For One Proportion: A Simulation Study, Özlem Güllü, Mustafa Agah Tekindal

Journal of Modern Applied Statistical Methods

The objective of non-inferiority trials is to demonstrate the efficiency of a novel treatment whether it is acceptably less or more efficient than a control or active (existing) treatment. They are employed in situations where, when compared to the active treatment, the novel treatment is to be advantageous with higher rates of reliability, compatibility, cost-efficiency, etc. Odds ratio is the most significant measure used in investigating the size of efficiency of treatments relative to one another. The purpose of the study is to calculate and evaluate the sample size under different scenarios based on three different test statistics in non-inferiority …

Adaptive Randomization Designs, Jenna Colavincenzo

Statistics

Adaptive design methodologies use prior information to develop a clinical trial design. The goal of an adaptive design is to maintain the integrity and validity of the study while giving the researcher flexibility in identifying the optimal treatment. An example of an adaptive design can be seen in a basic pharmaceutical trial. There are three phases of the overall trial to compare treatments and experimenters use the information from the previous phase to make changes to the subsequent phase before it begins.

Adaptive design methods have been in practice since the 1970s, but have become increasingly complex ever since. One …

On The Power Function Of Bayesian Tests With Application To Design Of Clinical Trials: The Fixed-Sample Case, Lyle Broemeling, Dongfeng Wu

Journal of Modern Applied Statistical Methods

Using a Bayesian approach to clinical trial design is becoming more common. For example, at the MD Anderson Cancer Center, Bayesian techniques are routinely employed in the design and analysis of Phase I and II trials. It is important that the operating characteristics of these procedures be determined as part of the process when establishing a stopping rule for a clinical trial. This study determines the power function for some common fixed-sample procedures in hypothesis testing, namely the one and two-sample tests involving the binomial and normal distributions. Also considered is a Bayesian test for multi-response (response and toxicity) in …