Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents - PubMed (original) (raw)
Practice Guideline
. 2010 Mar 15;16(6):1745-55.
doi: 10.1158/1078-0432.CCR-09-2167. Epub 2010 Mar 9.
Kevin K Dobbin, Susan Groshen, J Milburn Jessup, Andrew H Hruszkewycz, Maria Koehler, Ralph Parchment, Mark J Ratain, Lalitha K Shankar, Walter M Stadler, Lawrence D True, Amy Gravell, Michael R Grever; Biomarkers Task Force of the NCI Investigational Drug Steering Committee
Collaborators, Affiliations
- PMID: 20215558
- DOI: 10.1158/1078-0432.CCR-09-2167
Practice Guideline
Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents
Janet E Dancey et al. Clin Cancer Res. 2010.
Abstract
The National Cancer Institute (NCI) Investigational Drug Steering Committee (IDSC) charged the Biomarker Task Force to develop recommendations to improve the decisions about incorporation of biomarker studies in early investigational drug trials. The Task Force members reviewed biomarker trials, the peer-reviewed literature, NCI and U.S. Food and Drug Administration (FDA) guidance documents, and conducted a survey of investigators to determine practices and challenges to executing biomarker studies in clinical trials of new drugs in early development. This document provides standard definitions and categories of biomarkers, and lists recommendations to sponsors and investigators for biomarker incorporation into such trials. Our recommendations for sponsors focus on the identification and prioritization of biomarkers and assays, the coordination of activities for the development and use of assays, and for operational activities. We also provide recommendations for investigators developing clinical trials with biomarker studies for scientific rationale, assay criteria, trial design, and analysis. The incorporation of biomarker studies into early drug trials is complex. Thus the decision to proceed with studies of biomarkers should be based on balancing the strength of science, assay robustness, feasibility, and resources with the burden of proper sample collection on the patient and potential impact of the results on drug development. The Task Force provides these guidelines in the hopes that improvements in biomarker studies will enhance the efficiency of investigational drug development.
Similar articles
- An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics.
LoRusso PM, Boerner SA, Seymour L. LoRusso PM, et al. Clin Cancer Res. 2010 Mar 15;16(6):1710-8. doi: 10.1158/1078-0432.CCR-09-1993. Epub 2010 Mar 9. Clin Cancer Res. 2010. PMID: 20215546 Review. - Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice.
Kinders R, Parchment RE, Ji J, Kummar S, Murgo AJ, Gutierrez M, Collins J, Rubinstein L, Pickeral O, Steinberg SM, Yang S, Hollingshead M, Chen A, Helman L, Wiltrout R, Simpson M, Tomaszewski JE, Doroshow JH. Kinders R, et al. Mol Interv. 2007 Dec;7(6):325-34. doi: 10.1124/mi.7.6.9. Mol Interv. 2007. PMID: 18199854 Review. - The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.
Seymour L, Ivy SP, Sargent D, Spriggs D, Baker L, Rubinstein L, Ratain MJ, Le Blanc M, Stewart D, Crowley J, Groshen S, Humphrey JS, West P, Berry D. Seymour L, et al. Clin Cancer Res. 2010 Mar 15;16(6):1764-9. doi: 10.1158/1078-0432.CCR-09-3287. Epub 2010 Mar 9. Clin Cancer Res. 2010. PMID: 20215557 Free PMC article. - The NCI All Ireland Cancer Conference.
Johnston PG, Daly PA, Liu E. Johnston PG, et al. Oncologist. 1999;4(4):275-277. Oncologist. 1999. PMID: 10545862 - Novel designs and end points for phase II clinical trials.
Adjei AA, Christian M, Ivy P. Adjei AA, et al. Clin Cancer Res. 2009 Mar 15;15(6):1866-72. doi: 10.1158/1078-0432.CCR-08-2035. Epub 2009 Mar 10. Clin Cancer Res. 2009. PMID: 19276272 Review.
Cited by
- Design a Clinical Research Protocol: Influence of Real-World Setting.
Cimino J, Braun C. Cimino J, et al. Healthcare (Basel). 2023 Aug 10;11(16):2254. doi: 10.3390/healthcare11162254. Healthcare (Basel). 2023. PMID: 37628452 Free PMC article. Review. - Modeling factors critical for implementation of precision medicine at health systems-level: an IRT approach.
Mogaka JJ, Chimbari MJ. Mogaka JJ, et al. Am J Transl Res. 2021 Nov 15;13(11):12557-12574. eCollection 2021. Am J Transl Res. 2021. PMID: 34956473 Free PMC article. - Identification of direct target engagement biomarkers for kinase-targeted therapeutics.
Paweletz CP, Andersen JN, Pollock R, Nagashima K, Hayashi ML, Yu SU, Guo H, Bobkova EV, Xu Z, Northrup A, Blume-Jensen P, Hendrickson RC, Chi A. Paweletz CP, et al. PLoS One. 2011;6(10):e26459. doi: 10.1371/journal.pone.0026459. Epub 2011 Oct 24. PLoS One. 2011. PMID: 22039492 Free PMC article. - Clinical implication of prognostic and predictive biomarkers for castration-resistant prostate cancer: a systematic review.
Tian S, Lei Z, Gong Z, Sun Z, Xu D, Piao M. Tian S, et al. Cancer Cell Int. 2020 Aug 26;20:409. doi: 10.1186/s12935-020-01508-0. eCollection 2020. Cancer Cell Int. 2020. PMID: 32863768 Free PMC article. Review. - Opportunities and challenges facing biomarker development for personalized head and neck cancer treatment.
Lucs A, Saltman B, Chung CH, Steinberg BM, Schwartz DL. Lucs A, et al. Head Neck. 2013 Feb;35(2):294-306. doi: 10.1002/hed.21975. Epub 2012 Jan 27. Head Neck. 2013. PMID: 22287320 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical