National Comprehensive Cancer Network

About NCCN

White Paper and Summary Available: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

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.

The National Comprehensive Cancer Network® (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.

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.  

Visit NCCN.org/policy to download the in-depth summary of the Summit, as well as the white paper published in JNCCN – Journal of the National Comprehensive Cancer Network.