Created by the Collaboratory Biostatistics and Study Design Core
This biostatistical research tool set includes a series of guidance documents developed by the Collaboratory Biostatistics and Study Design Core. These documents, which focus on detailed aspects of statistical design for conducting pragmatic clinical trials, provide a synthesis of current developments, discuss possible future directions, and, where appropriate, make recommendations for application to pragmatic clinical research.
Please note: all documents listed below open as Adobe PDFs. If you do not have software that can open a PDF, click here to download a free version of Adobe Acrobat Reader.
Currently Available Biostatistical Guidances
- Key Issues in Extracting Usable Data from Electronic Health Records for Pragmatic Clinical Trials
- The Intraclass Correlation Coefficient
- Unequal Cluster Sizes in Cluster-Randomized Clinical Trials
- Pair-Matching vs Stratification in Cluster-Randomized Trials
- Frailty Models in Cluster-Randomized Trials
- Small-Sample Robust Variance Correction for Generalized Estimating Equations for Use in Cluster-Randomized Trials
The Biostatistics and Study Design Core wishes to thank David M. Murray, PhD, Director, Office of Disease Prevention, National Institutes of Health, for his invaluable input into the creation of these research tools.
This work is supported by the National Institutes of Health (NIH) Common Fund, through a cooperative agreement (U54 AT007748) from the Office of Strategic Coordination within the Office of the NIH Director. The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
Originally published on July 15, 2014.
Updated on October 12, 2015.
- Questions or comments regarding these guidance documents can be submitted via email. Please add “Living Textbook” to the Subject line of the email.