Medical Writing Obesity and Type 2 Diabetes Regulatory Writing

Volume 21, Issue 4 - Obesity and Type 2 Diabetes

Regulatory Writing

Abstract

The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go into any deep analysis or attempt to put the trial into context. The line of argument is that the best place to really discuss the findings is in the integrated summaries, where pooled data are presented and the focus is on the big picture. And as company positions may change over time, a discussion section that is too detailed and assertive may cause problems later. The ‘shorter is better’ approach is no doubt sound advice that is widely applicable, particularly to CSRs that will generally be read as part of a submission

References

  1. E3 Implementation Working Group ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 6 July 2012 [cited 2012 Sep 1]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_QAs_R1_Step4.pdf
  2. ICH harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports, E3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Step 4, 30 November 1995 [cited 2012 Sep 1] Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf

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Articles

The horror and the pity: Obesity and diabetes
Passing the torch
Message from the President
Obesity: When weight becomes unbearable
Genetics and environmental factors in obesity and diabetes: Complex problems, complex solutions
New treatments for type 2 diabetes
Is exercise physiology a real science?
What is the best quality of diabetes care? The Global Diabetes Survey needs your participation
The importance of Health Research in Horizon 2020: Diabetes as a model of a chronic disease and the need for sustainable funding
Is anyone stealing your articles? Exploding copyright myths
Paragraphing (Part 1 of 2)
Improving patient communication by writing with empathy
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English grammar and style
Medical Journalism
Out On Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk