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.
Download the full article
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
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk