Medical Writing Vaccines and Immunotherapies Changing methods to assess targeted therapies in oncology
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Volume 27, Issue 1 - Vaccines and Immunotherapies

Changing methods to assess targeted therapies in oncology

Abstract

New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In traditional cytotoxic chemotherapy trials, we observe a positive correlation between dose toxicity and dose efficacy. In targeted therapy trials, however, high doses can sometimes be well tolerated and increasing the dose beyond a certain level does not increase tumour response. Early clinical trials in targeted therapies therefore need to simultaneously assess toxicity and provide early signals of efficacy, based on biomarkers when available. Phase II primary endpoints have also been questioned, since the RECIST (Response Evaluation Criteria in Solid Tumour) is not well suited to functional modifications in tumours. New phase III trials, with more homogeneous targeted populations, are using more flexible designs, including interim analyses and adaptive designs. These flexible designs allow the sample size, and sometimes the trial design, to be modified during the trial. This article discusses these new methodological challenges for evaluating targeted therapies.

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Articles

Vaccines and immunotherapies
President's Column
A history of EMWA
EMWA News
An introduction to vaccines and immunotherapies
Immuno-oncology: Harnessing our immune system to fight cancer
Changing methods to assess targeted therapies in oncology
HIV vaccine clinical trials: An overview
Allergen immunotherapy in the European regulatory environment
Pharmacovigilance for vaccines and immunotherapies
Addressing vaccine hesitancy in writing
Results of the 2017 EMWA salary survey
Lay writing: Strategies for improving assent forms
The perils of the unknown: Missing data in clinical studies
Medical writing in China: Trends and opportunities
PhD student: A medical writer in the making!
News from the EMA
Medical Communications
Journal Watch
In the Bookstores
The Webscout
Lingua Franca and Beyond
Teaching Medical Writing
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Entering medical communications as a non-native English speaker
Out on Our Own

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