News Details
NCCN to Host Policy Summit Concerning Biomarkers and Targeted Therapies in Clinical Trial Design
The National Comprehensive Cancer Network® (NCCN®) will host Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies on April 25, 2014 in Bethesda, Maryland, as part of the NCCN Oncology Policy Program.
FORT WASHINGTON, PA – On April 25, 2014, the National Comprehensive Cancer Network® (NCCN®) will host the NCCN Oncology Policy Summit titled, Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies, at the Bethesda Marriott in Bethesda, Maryland.
With cancer 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 trial results are significant problems for pharmaceutical companies, clinicians, statisticians, and regulators. These issues will need to be addressed in order to meet the needs of people with cancer.
"Groundbreaking research advancements in oncology and the development of biomarkers and targeted therapies present unique challenges in clinical trial design," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "The NCCN Oncology Policy Summit will shed light on the complexities of statistical 'certainty' in small patient populations, consider reimbursement for biomarker testing for eligibility in clinical trial enrollment, and present debate about whether conventional clinical trial design is practical in this new treatment environment."
In preparation for the Summit, NCCN convened a Clinical Trials Work Group, chaired by Alan P. Venook, MD, UCSF Helen Diller Family Comprehensive Cancer Center, on March 20, 2014, in Philadelphia, Pennsylvania, to deliberate relevant topics such as, but not limited to general issues to consider in clinical trials design for multiple biomarkers and targeted therapies and disease specific considerations in biomarker/multi-agent clinical trial design.
The NCCN Clinical Trials Work Group members included: Maria E. Arcila, MD, Memorial Sloan-Kettering Cancer Center; Al B. Benson III, MD, FACP, Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Donald A. Berry, PhD, The University of Texas MD Anderson Cancer Center; Marian Birkeland, PhD, NCCN; D. Ross Camidge, MD, PhD, University of Colorado Cancer Center; Robert W. Carlson, MD, NCCN; Toni K. Choueiri, MD, Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center; Valerie Guild, Aim at Melanoma Foundation; Gregory P. Kalemkerian, MD, University of Michigan Comprehensive Cancer Center; Razelle Kurzrock, MD, UC San Diego Moores Cancer Center; Christine M. Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center; Joan S. McClure, MS, NCCN; Amy E. McKee, MD, U.S. Food and Drug Administration (FDA); Robert J. Morgan, Jr., MD, FACP, City of Hope Comprehensive Cancer Center; Anthony J. Olszanski, MD, Fox Chase Cancer Center; Mary W. Redman, PhD, Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance; Vered Stearns, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; and Alan P. Venook, MD, UCSF Helen Diller Family Comprehensive Cancer Center.
The Work Group concluded, in part, that trial design needs to include protocols with earlier endpoints to accommodate sequential therapies within the clinical trial, clinical trial partnerships need to be expanded from the traditional NCI Cooperative group model to a broader collection of interested stakeholders in order to ensure adequate funding, and payment systems for biomarker testing to establish eligibility for clinical trials are needed even when expected yield of eligible patients is small.
"It is commonly said that our goal is to personalize cancer care and we appear to have the tools with which to do that," said Dr. Venook. "The challenge is identifying the right patients and treatments and proving that they work. To do that, we will need to work together with all stakeholders, including NCI, pharmaceutical industry, patients, advocates, doctors, and insurers. We hope to start the dialogue on April 25."
The full scope of recommendations from the Work Group will be presented at the Summit, followed by roundtable panel discussions that will explore additional regulatory, coverage, reimbursement, and policy issues. Panel members for the Summit include, but are not limited to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel Chairs and Panel Members, as well as representatives from FDA, Centers for Medicare and Medicaid Services (CMS), National Cancer Institute (NCI), industry, and payers.
Following the culmination of the Summit, an NCCN Clinical Trials Monograph, which will included the Work Group recommendations along with discussion points and conclusions derived at the Summit, will be published as a JNCCN – Journal of the National Comprehensive Cancer Network supplement.
For more information about the NCCN Oncology Policy Summit: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies, or to register for the event, visit NCCN.org.