May 28, 2020: New Updates to Design and Analysis Plan Chapters in the Living Textbook

The annual update of the Living Textbook has brought new content and organization to the Experimental Designs and Analysis Plan chapters. We invite you to explore these chapters and the external resources linked from the resources sidebar in each section.

The NIH Collaboratory Coordinating Center regularly refreshes content in the Living Textbook to improve the robust collection of resources it offers to the wider research community about how to plan and implement pragmatic clinical trials.

Sections of the Experimental Designs and Randomization Schemes chapter include:

  • Statistical Design Considerations
  • Cluster Randomized Trials
  • Randomization Methods
  • Choosing Between Cluster and Individual Randomization
  • Alternative Cluster Randomized Designs
  • Concealment and Blinding
  • Designing to Avoid Identification Bias
  • Additional Resources

Sections of the Analysis Plan chapter include:

  • Intraclass Correlation
  • Unequal Cluster Sizes
  • Accounting for Residual Confounding in the Analysis
  • Missing Data and Intention-to-Treat Analyses
  • EHR Data Extraction
  • Unanticipated Changes
  • Case Study: STOP CRC Trial