The impact of companion diagnostic device measurement performance on clinical validation of personalized medicine

Statistics in Medicine
Meijuan LiYun-Fu Hu

Abstract

A key component of personalized medicine is companion diagnostics that measure biomarkers, for example, protein expression, gene amplification or specific mutations. Most of the recent attention concerning molecular cancer diagnostics has been focused on the biomarkers of response to therapy, such as V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations in metastatic colorectal cancer, epidermal growth factor receptor mutations in metastatic malignant melanoma. The presence or absence of these markers is directly linked to the response rates of particular targeted therapies with small-molecule kinase inhibitors or antibodies. Therefore, testing for these markers has become a critical step in the target therapy of the aforementioned tumors. The core capability of personalized medicine is the companion diagnostic devices' (CDx) ability to accurately and precisely stratify patients by their likelihood of benefit (or harm) from a particular therapy. There is no reference in the literature discussing the impact of device's measurement performance, for example, analytical accuracy and precision on treatment effects, variances, and sample sizes of clinical trial for the personalized medicine. In this paper, using both ...Continue Reading

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Citations

Aug 2, 2016·Statistics in Medicine·Solomon HarrarLeonid Kalachev
Feb 2, 2017·Statistics in Medicine·Xin HuangViswanath Devanarayan
Nov 2, 2018·Therapeutic Innovation & Regulatory Science·Zhiheng Xu, Meijuan Li

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