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

Abstract

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.

Download the full article

References

  1. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010–2020. J Natl Cancer Inst 2011;103:117–28.
  2. Le Tourneau C, Razak AR, Gan HK, Pop S, Diéras V, Tresca P, et al. Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: a review of the literature. Eur J Cancer 2011;47:1468–75.
  3. LoConte NK, Cleary JF, Bozeman J, Wilding G, Alberti D, Setala A, et al. Predictors of dose limiting toxicities in phase I clinical trials: the impact of age, comorbidity, and other clinical and non-clinical factors. J Clin Oncol 2008;15S:9525.
  4. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205–16.
  5. Schilsky L. End points in cancer clinical trials and the drug approval process. Clin Cancer Res 2002;8:935–8.

Search

Articles

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

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

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