Back to Journals » Comparative Effectiveness Research » Volume 5

Implementation of comparative effectiveness research in personalized medicine applications in oncology: current and future perspectives

Authors IJzerman MJ, Manca A, Keizer J, Ramsey SD

Received 11 July 2015

Accepted for publication 20 August 2015

Published 26 November 2015 Volume 2015:5 Pages 65—72

DOI https://doi.org/10.2147/CER.S92212

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Azza AbuDagga

Peer reviewer comments 3

Editor who approved publication: Professor Matthew Maciejewski

Maarten J IJzerman,1,3 Andrea Manca,2,3 Julia Keizer,1 Scott D Ramsey4

1Department of Health Technology and Services Research, University of Twente, Enschede, the Netherlands; 2Centre for Health Economics, University of York, York, UK; 3Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg, 4Fred Hutchinson Cancer Research Center, Seattle, WA, USA

Abstract: Personalized medicine (PM) or precision medicine has been defined as an innovative approach that takes into account individual differences in people's genes, environments, and lifestyles in prevention and treatment of disease. In PM, genomic information may contribute to the molecular understanding of disease, to optimize preventive health care strategies, and to fit the best drug therapies to the patient's individual characteristics. Evidence development in the era of genomic medicine is extremely challenging due to a number of factors. These include the rapid technological innovation in molecular diagnostics and targeted drug discoveries, and hence the large number of mutations and multiple ways these may influence treatment decisions. Although the evidence base for PM is evolving rapidly, the main question to be explored in this article is whether existing evidence is also fit for comparative effectiveness research (CER). As a starting point, this paper therefore reflects on the evidence required for CER and the evidence gaps preventing decisions on market access and coverage. The paper then discusses challenges and potential barriers for applying a CER paradigm to PM, identifies common methodologies for designing clinical trials in PM, discusses various approaches for analyzing clinical trials to infer from population to individual level, and presents an example of a clinical trial in PM (The RxPONDER TRIAL) demonstrating good practice. The paper concludes with a future perspective, including modeling approaches for evidence synthesis.

Keywords: personalized medicine, precision medicine, comparative effectiveness research, health technology assessment, oncology, genomics
 

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Readers of this article also read:

Monitoring cancer stem cells: insights into clinical oncology

Lin SC, Xu YC, Gan ZH, Han K, Hu HY, Yao Y, Huang MZ, Min DL

OncoTargets and Therapy 2016, 9:731-740

Published Date: 11 February 2016

Personalized medicine and stroke prevention: where are we?

Kim J, Thrift AG, Nelson MR, Bladin CF, Cadilhac DA

Vascular Health and Risk Management 2015, 11:601-611

Published Date: 2 December 2015

mTOR signaling in the neuropathophysiology of depression: current evidence

Réus GZ, Quevedo J, Rodrigues AL

Journal of Receptor, Ligand and Channel Research 2015, 8:65-74

Published Date: 23 November 2015

Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials

Van Heertum RL, Scarimbolo R, Ford R, Berdougo E, O’Neal M

Drug Design, Development and Therapy 2015, 9:5215-5223

Published Date: 11 September 2015

Tracking the 2015 Gastrointestinal Cancers Symposium: bridging cancer biology to clinical gastrointestinal oncology

Aprile G, Leone F, Giampieri R, Casagrande M, Marino D, Faloppi L, Cascinu S, Fasola G, Scartozzi M

OncoTargets and Therapy 2015, 8:1149-1156

Published Date: 22 May 2015

Palliative nursing care for children and adolescents with cancer

Foster TL, Bell CJ, McDonald CF, Harris JS, Gilmer MJ

Nursing: Research and Reviews 2012, 2:17-25

Published Date: 15 June 2012

Multidisciplinary care in pediatric oncology

Cantrell MA, Ruble K

Journal of Multidisciplinary Healthcare 2011, 4:171-181

Published Date: 30 May 2011