Introduction

Analysis Plan


Section 1

Introduction

Contributor

Elizabeth R. DeLong, PhD

For the NIH Health Care Systems Collaboratory Biostatistics and Study Design Core

 

Contributing Editors

Jonathan McCall, MS

Damon M. Seils, MA

Pragmatic clinical trial (PCT) designs, particularly ones that use cluster randomization or other novel methods, pose challenges during the study design phase (Cook et al, 2016). Here, we briefly examine some current challenges in PCT design, as well as potential solutions and future directions for further exploration.

SECTIONS

CHAPTER SECTIONS

REFERENCES

back to top

Cook AJ, Delong E, Murray DM, Vollmer WM, Heagerty PJ. 2016. Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials. 13:504-512. doi:10.1177/1740774516646578. PMID: 27179253.


Version History

January 16, 2019: Made nonsubstantive changes to the text as part of the annual content update (changes made by D. Seils).

Published August 25, 2017

Citation:

DeLong ER. Analysis Plan: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/analysis-plan-top/analysis-plan-introduction/. Updated January 17, 2019. DOI: 10.28929/015.