Medical Writing Medical Writing in Oncology Medical writing for cancer trials and submissions

Volume 21, Issue 1 - Medical Writing in Oncology

Medical writing for cancer trials and submissions


Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical conduct of clinical trials in cancer, including difficulties with performing placebo-controlled studies, blinding, and restricting off-protocol treatments that may impact on trial results. Overall survival is the gold-standard efficacy endpoint for cancer trials, but reliable results can require a long duration of follow-up. Other endpoints such as time to progression and tumour response rates are therefore also used. Where treatments are targeted at specific disease mechanisms, biological endpoints may also be assessed. Safety evaluations require an understanding of the effects of the disease and its treatment on the likely observed events and abnormalities. A thorough understanding of the specifics of the disease under investigation and established as well as experimental approaches to its treatment can help medical writers to produce consistent and accurate documentation throughout clinical development.

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About the Medical Writing Journal
Oncology and medical writers
Message from the President
The war on cancer – What is the enemy, and are we winning?
Medical writing for cancer trials and submissions
Developing a treatment for ovarian cancer
The evolving landscape of medical education in oncology
Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs
Identifying appropriate journals in which to publish original research on vaccines against human infectious diseases
New myths about English
From researcher in Europe to medical writer in India
Imaging techniques in oncology
Is cancer preventable? A literature review
A rising tide: Hospitals and social media
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
Good Writing Practice
Out On Our Own
Translation Section


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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk