Clinical trials in the genomic era Journal Article

Authors: Joffe, E.; Iasonos, A.; Younes, A.
Article Title: Clinical trials in the genomic era
Abstract: Personalization of therapy to target specific molecular pathways has been placed in the forefront of cancer research. Initial reports from clinical trials designed to select patients for appropriate treatment on the basis of tumor characteristics not only have generated considerable excitement but also have identified several challenges. These challenges include the overcoming of regulatory and logistic difficulties, identification of the best selection biomarkers and diagnostic platforms that can be applied in the clinical setting, definition of relevant outcomes in small preselected patient populations, and the design of methods that facilitate rapid enrollment and interpretation of clinical trials by aggregating data across histologically diverse malignancies with common genetic alterations. Furthermore, because our knowledge of the functional consequences of many genetic alterations lags, investigators and sponsors struggle with choosing between ideal clinical trial designs and more practical ones. These challenges are amplified when more than one biomarker is used to select patients for a combination of targeted agents. This review summarizes the current status and challenges of clinical trials in the genomic era and proposes ways to address these challenges. © 2017 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 35
Issue: 9
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2017-03-20
Start Page: 1011
End Page: 1017
Language: English
DOI: 10.1200/jco.2016.70.8891
PROVIDER: scopus
PUBMED: 28297622
PMCID: PMC5652384
Notes: Review -- Export Date: 2 May 2017 -- Source: Scopus
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MSK Authors
  1. Alexia Elia Iasonos
    179 Iasonos
  2. Anas Younes
    195 Younes
  3. Erel Joffe
    3 Joffe