Meeting Improving Cancer Diagnosis and Care: The Clinical Application of Computational Methods and Big Data in Precision Oncology: A Workshop When: October 29, 2018 - October 30, 2018 (8:00 AM Eastern) Where: Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001 Topics Biomedical and Health Research, Diseases, Health Services, Coverage, and Access, Quality and Patient Safety Activity: National Cancer Policy Forum Board: Board on Health Care Services Genomic profiling is increasingly used in a one-gene/one-drug manner to determine cancer treatment plans, but the development of cancer is almost always multi-genic and multi-clonal. One recent clinical trial of the one-gene/one-drug strategy for cancer treatment showed no improvement compared to standard of care. A feature of precision cancer research and care is the generation of very large databases that combine ‘omics’ data with clinically annotated patient data. Thus, an increasing number of researchers are testing computational biology methods to interpret complex, high-dimensional data such as: (i) gene and chromosome mutations; (ii) clinical laboratory results; and (iii) radiographic results. Oversight bodies, such as scientific review committees, institutional review boards, and the FDA, have little specific guidance for the evaluation of multi-gene/multi-drug treatment approaches. As high complexity omics data become more widely available, the cancer community needs clear direction on how to conduct prospective evaluations of multiplexed diagnostic tests for treatment selection, and how to apply complex computational biology methods in precision cancer care to ensure both the safety of the patients and the integrity of scientific findings. Recognizing these challenges, the National Cancer Policy Forum developed a 2-workshop series to examine strategies to improve cancer diagnosis and care. The first workshop focused on patient access to expertise and technologies in oncologic imaging and pathology (held on February 12 – 13, 2018). The second public workshop will be held on October 29 – 30, 2018 to examine the clinical use of high-dimensional omics data and computational methods in precision oncology research and clinical care. The workshop will feature invited presentations and panel discussions on topics that may include: • Challenges and opportunities to use omics data to develop precision medicine approaches and technologies in cancer care. • Potential standards and best practices for computational software and methodological approaches for the use of big data to inform clinical care of patients with cancer, especially in regard to multi-parameter/multi-treatment testing and interpretation. • Potential opportunities to improve the translation of omics technologies into oncology practice, such as harmonization of standards for omics-based discovery, development and evaluation; data sharing and reproducibility; oversight and regulation; education, training, and workforce needs; and the use of dissemination and implementation science strategies. More information about the workshop will be forthcoming.