Introduction

Analysis Plan

Section 1

Introduction

Contributor

Elizabeth R. DeLong, PhD

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

 

Contributing Editor

Jonathan McCall, MS

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

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: http://www.rethinkingclinicaltrials.org/analysis-plan-top/analysis-plan-introduction/. Updated August 24, 2017.