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Challenges and methodology in the incorporation of biomarkers in cancer clinical trials.

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Title: Challenges and methodology in the incorporation of biomarkers in cancer clinical trials.
Authors: Wilhelm-Benartzi, CS
Mt-Isa, S
Fiorentino, F
Brown, R
Ashby, D
Item Type: Journal Article
Abstract: Biomarkers can be used to establish more homogeneous groups using the genetic makeup of the tumour to inform the selection of treatment for each individual patient. However, proper preclinical work and stringent validation are needed before taking forward biomarkers into confirmatory studies. Despite the challenges, incorporation of biomarkers into clinical trials could better target appropriate patients, and potentially be lifesaving. The authors conducted a systematic review to describe marker-based and adaptive design methodology for their integration in clinical trials, and to further describe the associated practical challenges. Studies published between 1990 to November 2015 were searched on PubMed. Titles, abstracts and full text articles were reviewed to identify relevant studies. Of the 4438 studies examined, 57 studies were included. The authors conclude that the proposed approaches may readily help researchers to design biomarker trials, but novel approaches are still needed.
Issue Date: 21-Dec-2016
Date of Acceptance: 12-Dec-2016
URI: http://hdl.handle.net/10044/1/44684
DOI: https://dx.doi.org/10.1016/j.critrevonc.2016.12.008
ISSN: 1040-8428
Publisher: Elsevier
Start Page: 49
End Page: 61
Journal / Book Title: Critical Reviews in Oncology/Hematology
Volume: 110
Issue: 2017
Copyright Statement: © 2016 Elsevier Ireland Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor/Funder: Cancer Research UK
National Institute for Health Research
Ovarian Cancer Action
Funder's Grant Number: 15589
RDEMC 79560
N/A
Keywords: Biomarkers
Cancer
Clinical trials
Research design
Statistical
Biomarkers, Tumor
Clinical Trials as Topic
Humans
Neoplasms
Research Design
Oncology & Carcinogenesis
1102 Cardiovascular Medicine And Haematology
Publication Status: Published
Conference Place: Netherlands
Appears in Collections:Division of Surgery
Division of Cancer
Faculty of Medicine
Epidemiology, Public Health and Primary Care



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