RT Journal Article
SR Electronic
T1 Implementation of Validated Pharmacodynamic Assays in Multiple Laboratories: Challenges, Successes, and Limitations
JF Clinical Cancer Research
JO Clin Cancer Res
FD American Association for Cancer Research
SP 2578
OP 2586
DO 10.1158/1078-0432.CCR-14-0476
VO 20
IS 10
A1 Kinders, Robert
A1 Ferry-Galow, Kate
A1 Wang, Lihua
A1 Srivastava, Apurva K.
A1 Ji, Jiuping (Jay)
A1 Parchment, Ralph E.
YR 2014
UL http://clincancerres.aacrjournals.org/content/20/10/2578.abstract
AB There is a “life cycle” of pharmacodynamic (PD) biomarker assays that guides the development and clinical implementation in our laboratories. The well-recognized elements of analytical assay validation and demonstration of fitness-for-purpose of the biomarker, specimen collection, handling, and assay methods are only a part of the required activities. Assay transfer across laboratories and testing on actual human clinical specimens are vital for understanding assay performance and robustness. In our experience, this patient specimen-centered approach has required assay method modifications, some unexpected, but which were critical to successful implementation in clinical trials. In addition, dispersing assays throughout the National Cancer Institute's clinical trials network has required the development of calibrator and control materials as well as formal training courses for smooth implementation. One measure of success of this approach has been that a number of the assays developed at NCI's Frederick National Laboratory have ultimately reached the stage of commercialization, enabling wide accessibility of the PD biomarker assays by the research community. See all articles in this CCR Focus section, “Progress in Pharmacodynamic Endpoints.” Clin Cancer Res; 20(10); 2578–86. ©2014 AACR.