The Ethics of Study Design

Because including humans (and animals) in a clinical trial exposes them to risk, we must design all aspects of the clinical trial ethically. Others can better discuss how consent, protection of protected populations and similar topics should be handled. I want to focus instead on how the statistical design of a clinical trial impacts the ethics of the trial.

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The Bayesian Approach to Sample Size Calculations

Sample Size determination is generally done using a frequentist approach. However, Bayesian approaches can also be used allowing a researcher to take into account prior information as well as handle uncertainty about parameters used in the frequentist approach.

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Using Pilot Studies in Clinical Research

A pilot study is a smaller version of a planned study. The purpose of the pilot study is to test the design of the larger study to improve its likelihood of success. Unfortunately, there are several misconceptions about what a pilot study is for.

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