National Comprehensive Cancer Network

Educational Events & Programs

2014 NCCN Policy Summit: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

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With cancers increasingly recognized as being comprised of many subtypes differentiated by specific molecular profiles, identifying the most effective combination therapies is challenging. Defining appropriate patient subsets, selecting agents active against specific targets, predicting effective therapeutic combinations, and appropriately interpreting clinical trials results are significant problems for pharmaceutical companies, clinicians, statisticians, and regulators which will need to be addressed in order to meet the needs of cancer patients.

NCCN convened a Work Group consisting of thought leaders in areas of clinical research, medical oncology, and biostatistics to address the above concerns. The Work Group was charged with identifying areas of need and establishing recommendations to address how clinical trials can be designed and executed for stratified patient populations and how clinical trials can address multi-drug regimens and subtle treatment effects.

NCCN Clinical Trials Work Group

Maria E. Arcila, MD, Acting Director, Diagnostic Molecular Pathology Laboratory, Memorial Sloan-Kettering Cancer Center

Al B. Benson III, MD, FACP, Professor of Medicine, Robert H. Lurie Comprehensive Cancer
Center of Northwestern University

Donald A. Berry, PhD, Biostatistician, The University of Texas MD Anderson Cancer Center

Marian Birkeland, PhD, Senior Director, Compendia Development, National Comprehensive
Cancer Network

D. Ross Camidge, MD, PhD, Associate Professor of Medicine/Oncology, University of Colorado
Cancer Center

Robert W. Carlson, MD, Chief Executive Officer, National Comprehensive Cancer Network

Toni K. Choueiri, MD, Attending Physician, Division of Solid Tumor Oncology, Dana-Farber/Brigham and Women's Cancer Center Massachusetts General Hospital Cancer Center

Valerie Guild, President, Aim at Melanoma Foundation

Gregory P. Kalemkerian, MD, Co-Director, Thoracic Oncology, University of Michigan
Comprehensive Cancer Center

Razelle Kurzrock, MD, Senior Deputy Center Director, UC San Diego Moores Cancer Center

Christine M. Lovly, MD, PhD, Assistant Professor of Medicine and Cancer Biology, Vanderbilt-Ingram Cancer Center

Joan S. McClure, MS, Senior Vice President, Clinical Information and Publications, National Comprehensive Cancer Network

Amy E. McKee, MD, Team Leader, Breast and Gynecologic Cancer 2, US Food and Drug Administration

Robert J. Morgan, Jr., MD, FACP, Staff Physician, Department of Medical Oncology, City of Hope Comprehensive Cancer Center

Anthony J. Olszanski, MD, Director, Phase I Program, Fox Chase Cancer Center

Mary W. Redman, PhD, Associate Member, Fred Hutchinson Cancer Research Center/
Seattle Cancer Care Alliance

Vered Stearns, MD, Associate Professor, The Sidney Kimmel Comprehensive
Cancer Center at Johns Hopkins

Alan P. Venook, MD (Chairperson), Professor, Clinical Medicine, UCSF Helen Diller Family Comprehensive Cancer Center

To present the findings of the Clinical Trials Work Group and discuss policy implications, NCCN hosted a Policy Summit: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies, on April 25, 2014 at the Bethesda Marriott in Bethesda, Maryland.  

Dr. Alan Venook, chairman of the NCCN Clinical Trials Work group, presented the Work Group’s conclusions and recommendations. His presentation was followed by two roundtable discussions moderated by Clifford Goodman, PhD, The Lewin Group. The first roundtable, Strategies for Implementation of Clinical Trials in the Era of Small Subsets and Multiple Agents, covered many topics including accruing patients for trials, clinical trial endpoints, and costs of conducting clinical trials. The day concluded with a second roundtable entitled Identifying and Defining Standards of Care for Cancer Subtypes. Topics for discussion included coverage and reimbursement of biomarker testing, value of biomarkers, and inclusion of biomarkers in guidelines.

The findings and recommendations of the NCCN Clinical Trials Work Group will be published as a JNCCN supplement in October of 2014.

Click here for in-depth summary.

If you have questions about NCCN Policy Summits, please contact Jessica DeMartino, Manager, Health Policy Programs.