Volume 25, Issue 3 - Statistics
Biostatistics and medical writing: Synergy in preparing clinical trials documents
Authors: Raquel Billiones, Scott Miller
Abstract
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This article demonstrates how biostatisticians and medical writers should work together to streamline the document preparation process and ensure the quality of these documents.
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References
- ICH E9(R1) Final Concept Paper. Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials. 2014 Oct 22 [cited 2016 Jun]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9_R1_Final_Concept_Paper_October_23_2014.pdf
- ICH E3 Guideline. Structure and Content of Clinical Study Reports. 1997 [cited 2016 Jun]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
- CORE (Clarity and Openness in Reporting: E3-based) Reference. 2016 May 03 [cited 2016 Jun]. Available from: http://www.core-reference.org/media/1032/core-reference-v1_0.pdf
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