Medical Writing Statistics Biostatistics and medical writing: Synergy in preparing clinical trials documents
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Volume 25, Issue 3 - Statistics

Biostatistics and medical writing: Synergy in preparing clinical trials documents

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

  1. 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
  2. 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
  3. 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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Articles

Statistics for medical writers
President's Message
EMWA News
History of biostatistics
The illusion of certainty and the certainty of illusion
Never P alone: The value of estimates and confidence intervals
A medical writer's guide to meta-analysis
Study design made easy
Statistical analyses and methods in the published literature: The SAMPL guidelines
How to interpret and report the results from multivariable analyses
Biostatistics and medical writing: Synergy in preparing clinical trials documents
Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO
Where have all the UK entry level pharmaceutical regulatory medical writing jobs gone?
News from the EMA
Journal Watch
In the Bookstores
The Webscout
Good Writing Practice
Medical Communications
Getting Your Foot in the Door
Lingua Franca and Beyond
Gained in Translation
Teaching Medical Writing
Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts
Out On Our Own

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