NCCN working group report: Designing clinical trials in the era of multiple biomarkers and targeted therapies

Alan P. Venook, Maria E. Arcila, Al B. Benson, Donald A. Berry, David Ross Camidge, Robert W. Carlson, Toni K. Choueiri, Valerie Guild, Gregory P. Kalemkerian, Razelle Kurzrock, Christine M. Lovly, Amy E. McKee, Robert J. Morgan, Anthony J. Olszanski, Mary W. Redman, Vered Stearns, Joan McClure, Marian L. Birkeland

Research output: Contribution to journalArticle

Abstract

Defining treatment-susceptible or -resistant populations of patients with cancer through the use of genetically defined biomarkers has revolutionized cancer care in recent years for some disease/patient groups. Research continues to show that histologically defined diseases are diverse in their expression of unique mutations or other genetic alterations, however, which presents opportunities for the development of personalized cancer treatments, but increased difficulty in testing these therapies, because potential patient populations are divided into ever smaller numbers. To address some of the growing challenges in biomarker development and clinical trial design, NCCN assembled a group of experts across specialties and solid tumor disease types to begin to define the problems and to consider alternate ways of designing clinical trials in the era of multiple biomarkers and targeted therapies. Results from that discussion are presented, focusing on issues of clinical trial design from the perspective of statisticians, clinical researchers, regulators, pathologists, and information developers.

Original languageEnglish (US)
Pages (from-to)1629-1649
Number of pages21
JournalJNCCN Journal of the National Comprehensive Cancer Network
Volume12
Issue number11
DOIs
StatePublished - Nov 1 2014
Externally publishedYes

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ASJC Scopus subject areas

  • Oncology

Cite this

Venook, A. P., Arcila, M. E., Benson, A. B., Berry, D. A., Camidge, D. R., Carlson, R. W., Choueiri, T. K., Guild, V., Kalemkerian, G. P., Kurzrock, R., Lovly, C. M., McKee, A. E., Morgan, R. J., Olszanski, A. J., Redman, M. W., Stearns, V., McClure, J., & Birkeland, M. L. (2014). NCCN working group report: Designing clinical trials in the era of multiple biomarkers and targeted therapies. JNCCN Journal of the National Comprehensive Cancer Network, 12(11), 1629-1649. https://doi.org/10.6004/jnccn.2014.0161