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.

Keywords:

• Cancer
• Clinical trials
• Medical writing

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• Graham Guest ([email protected]) offers coaching for simplicity, grammar coaching, and consulting on the English language, continuing professional development and lifelong learning. He has a background in the management and administration of international professional associations, and experience as a career coach and a psychological counsellor.

Additional information

Notes on contributors

James M Visanji

James Visanji holds a PhD in medicine from Manchester University and the Chartered Institute of Linguists Diploma in Translation. Prior to joining Accovion's medical writing team in 2006, James worked as a research fellow at the European Institute of Oncology in Milan, and subsequently as a freelance translator.