Applied Statistics in Clinical Trials
BS851: Statistical research design considerations, including randomization and sample size
determination, and methods for analyzing and interpreting statistical results from clinical trials.
Introduction to Clinical Trials
A clinical trial is defined as a prospective study comparing the effect or value of an interventi...
Randomization of Subjects
Subjects are assigned to study groups by a random mechanism not controlled by the patient or the ...
Continuous and Binary Endpoints
Outcomes are either continuous or dichotomous. Primary and secondary outcomes must be defined a p...
Baseline Variable Adjustment
Baseline covariates are variables expected to influence the outcome, measured before the start of...
Survival Analysis in Clinical Trials
We've already covered survival analysis in great detail here. This will be review, application to...
Multiple Comparisons
There are some situations where it may be necessary to have multiple hypothesis tests; ANOVA with...
Non-Inferiority in Clinical Trials
Usually clinical trials should show if a new treatment is superior to placebo or no treatment, bu...
Effect Modification and Interaction
Interaction is when a treatment effect is different across different subgroups of the population ...
Interim Analysis and Data Monitoring
Clinical trials are often longitudinal in nature. It is often impossible to enroll all subjects a...
Correlated Data in Clincal Trials
Note: My BS857 Notebook on Correlated Data goes much further in depth than the below. So far we ...