Clinical Trials Methodology

• Trial Protocol Tool from http://www.practihc.org, the PRACTIHC collaboration - Pragmatic RAndomized Controlled Trials in Health Care
  • Note: This resource is only to be used by nonprofit entities
• Some Sample Size and Power Considerations for Clinical Studies
• Papers on reporting of clinical trials from the CONSORT group: Explanation and elaboration
• Glossary of clinical trials terms from CONSORT
• Sample graphical and tabular clinical trial report from the Statistical Data Analysis Center, Dept. of Biostatistics and Medical Informatics, U. Wisconsin-Madison.
• Other examples of graphical presentation of clinical data | rreport
• St. George's Hospital Medical School Statistics Guide for Research Grant Applications, including links to Randomization Software and Services
• Results of recent cardiovascular clinical trials.

Advanced Clinical Trial Design

• Adaptive, sequential, Bayesian, and Phase II-III Bridging designs
• Two-stage designs
• Biostatisticians very interested in advanced design: tatsuki.koyama@vanderbilt.edu, cindy.chen@vanderbilt.edu, lily.wang@vanderbilt.edu, f.harrell@vanderbilt.edu, yu.shyr@vanderbilt.edu, mary.dietrich@Vanderbilt.Edu, lei.xu@vanderbilt.edu, leene.choi@vanderbilt.edu, dan.ayers@vanderbilt.edu
  • Crossover trials: Cindy Chen, Dan Byrne
  • Titration studies: Mary Dietrich
• Clinical researchers interested in advanced design: kathryn.edwards@Vanderbilt.Edu, beth.malow@Vanderbilt.Edu