The Challenge: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies
By Elizabeth Danielson, MHA, Director of Payer and Employer Initiatives
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, detecting agents active against specific targets, predicting effective therapeutic combinations, and appropriately interpreting clinical trials results are significant challenges for pharmaceutical companies, clinicians, statisticians, researchers, and regulators, and these challenges will need to be addressed in order to meet the needs of cancer patients.
The National Comprehensive Cancer Network® (NCCN®) is taking a leading role in addressing these challenges by bringing together a multidisciplinary work group of thought leaders to address such issues and challenges and to provide recommendations. To provide for diverse perspectives, the work group will include oncologists, researchers, statisticians, and policy makers, and will be chaired by Alan Venook, MD, Madden Family Distinguished Professorship in Medical Oncology and Translational Research at UCSF Helen Diller Family Comprehensive Cancer Center—one of the 23 NCCN Member Institutions. In conjunction with the recommendations, the work group will prepare an NCCN Clinical Trials Monograph, which will be published as a supplement to JNCCN – Journal of the National Comprehensive Cancer Network.
On April 25, 2014, as part of its Oncology Policy Summit Series, NCCN will host Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies, which will be held at the Bethesda Marriott in Bethesda, Maryland. Clifford Goodman, PhD, from the Lewin Group, will moderate the event. The Summit will include presentation of the Work Group’s recommendations by Dr. Venook, followed by two panel discussions on strategies for implementation of clinical trials in the era of small subsets and multiple agents, as well as identifying and defining standards of care for cancer subtypes. Panel members will include a diverse group of stakeholders who will respond to the Working Group recommendations and discuss issues including but not limited to: clinical trial design, using biomarkers to define patient cohorts, patient cohort size, standards for consideration of data, and cooperation among stakeholders and intellectual property considerations .
This Summit is designed for multiple stakeholders, including physicians, industry, government, patient advocacy groups, patients, and other interested parties. To learn more about the Summit or to register, click here.