@article{5ad1ccf948444384a5ec7fb674b4f430,
title = "Compressing drug development timelines in oncology using phase '0' trials",
abstract = "The optimal evaluation of molecularly targeted anticancer agents requires the integration of pharmacodynamic assays into early clinical investigations. Phase '0' trials conducted under the new Exploratory Investigational New Drug Guidance from the US Food and Drug Administration can provide a platform to establish the feasibility of assays for target modulation in human samples, evaluate biomarkers for drug effects and provide pharmacokinetic data. Phase 0 trials could facilitate rational drug selection, identify therapeutic failures early, and might compress timelines for anticancer drug development. We expect that such trials will become a routine part of early-phase oncological drug development in the future.",
author = "Shivaani Kummar and Robert Kinders and Larry Rubinstein and Parchment, {Ralph E.} and Murgo, {Anthony J.} and Jerry Collins and Oxana Pickeral and Jennifer Low and Steinberg, {Seth M.} and Martin Gutierrez and Sherry Yang and Lee Helman and Robert Wiltrout and Tomaszewski, {Joseph E.} and Doroshow, {James H.}",
note = "Funding Information: This project has been funded in whole or in part with federal funds from the US National Cancer Institute, National Institutes of Health. The content of this publication does not necessarily reflect the views or policies of the US Department of Health and Human Services, nor does any mention of trade names, commercial products or organizations imply endorsement by the US Government. This research was supported by the Division of Cancer Treatment and Diagnosis and the Center for Cancer Research of the National Cancer Institute.",
year = "2007",
month = feb,
doi = "10.1038/nrc2066",
language = "English (US)",
volume = "7",
pages = "131--139",
journal = "Nature Reviews Cancer",
issn = "1474-175X",
publisher = "Nature Publishing Group",
number = "2",
}