Common Design and Analysis Issues in Clinical Trials

Design and analysis issues for economic analysis alongside clinical trials.

INTRODUCTION Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. OBJECTIVE The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. ...

Causal and Design Issues in Clinical Trials

The first part of my dissertation focuses on post-randomization modification of intent-to-treat effects. For example, in the field of behavioral science, investigations involve the estimation of the effects of behavioral interventions on final outcomes for individuals stratified by post-randomization moderators measured during the early stages of the intervention (e.g., landmark analyses in can...

Simulated Clinical Trials: Some Design Issues

Simulation is widely used to investigate real-world systems in a large number of fields, including clinical trials for drug development, since real trials are costly, frequently fail and may lead to serious side effects. This paper is a survey of the statistical issues arising in these simulated trials, with particular emphasis on the design of virtual experiments, stressing similarities and di...

Cluster randomized clinical trials in orthodontics: design, analysis and reporting issues.

Cluster randomized trials (CRTs) use as the unit of randomization clusters, which are usually defined as a collection of individuals sharing some common characteristics. Common examples of clusters include entire dental practices, hospitals, schools, school classes, villages, and towns. Additionally, several measurements (repeated measurements) taken on the same individual at different time poi...

ST4241: Design and Analysis of Clinical Trials