Introduction -archived

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Archived on July 2, 2026

Design/ Analysis Plan - Introduction

Introduction -archived

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

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REFERENCES

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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.

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Version History

April 30, 2024: Made nonsubstantive changes to the text as part of the annual content update (changes made D. Seils).

June 23, 2022: Updated the name of the NIH Collaboratory in the contributors list as part of the annual content update (changes made by D. Seils).

May 27, 2020: Added Heagerty to the contributors list and reordered the sections of this chapter as part the annual content update (changes made by D. Seils).

May 1, 2020: Made nonsubstantive formatting changes to the References section as part of the annual content update (changes made by D. Seils).

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

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Introduction -archived

Citation:

Heagerty PJ, DeLong ER; for the NIH Health Care Systems Research Collaboratory Biostatistics and Study Design Core. Introduction -archived: Introduction -archived. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/analysis-plan-introduction/. Updated July 2, 2026. DOI: 10.28929/015.