Open AccessOptimal design of trials to demonstrate the utility of genomically‐guided therapy: Putting Precision Cancer Medicine to the test
Author(s) -
Dienstmann Rodrigo,
Rodon Jordi,
Tabernero Josep
Publication year - 2015
Publication title -
molecular oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.332
H-Index - 88
eISSN - 1878-0261
pISSN - 1574-7891
DOI - 10.1016/j.molonc.2014.06.014
Subject(s) - precision medicine , clinical trial , medical physics , medicine , certification , cancer medicine , process (computing) , intensive care medicine , cancer , test (biology) , companion diagnostic , computer science , pathology , biology , paleontology , political science , law , operating system
The new age of Precision Cancer Medicine, with specific biomarkers being used to direct targeted agents, generally concerns only a subset of patients within a certain histopathologically defined tumor type. This paradigm is challenged by the need to perform widespread molecular screening in certified laboratories, with results available to clinicians within reasonable timeframe. Tumor heterogeneity and clonal evolution must be considered in the decision making process. Adaptive and innovative clinical trial designs exploring predictive algorithms and reconsideration of traditional efficacy endpoints are required to rapidly translate scientific discoveries into patient care. Furthermore, international collaboration in cancer research and open discussions on the availability of investigational agents will likely redefine the drug development and approval process in the coming years.