Leveraging “Real World Data” to Accelerate Progress in Cancer Medicine: Opportunities and Obstacles
Abstract: Historically, progress in cancer medicine stemmed from mechanistic basic research which led to the development of drugs tested in the context of randomized controlled trials. Although this process remains dominant and the basis for most FDA approved cancer medicines, the essential paradigm has been upended by the rapid growth of analytic and computational capacity to evaluate several data streams: 1) molecular data about patients’ tumors (“omic data); 2) clinical data gleaned from routine health care delivery; and, 3) direct patient-reported outcomes (PROs). This talk will focus on recent projects that seek to decrease the morbidity and mortality of cancer through better integration of these data streams. First, it will describe recent projects to engage patients as active research participants by reporting their symptom burden during participation in clinical trials. Second, it will describe initiatives to integrate genomic data with “phenomic” data about patients’ outcomes with specific case studies. In each case, challenges that have slowed or prevented realization of “precision medicine” and “rapid learning health care” and opportunities to accelerate progress through more effective collaboration between clinical and computational researchers will be emphasized.
Biography: Deb Schrag MD MPH is a practicing medical oncologist and a health services researcher. She is a Professor of Medicine at Harvard Medical School and the Chief of the Division of Population Sciences at Dana Farber Cancer Institute. Her research focuses on measuring and improving the quality and effectiveness of cancer care such that the results achieved in the context of clinical trials achieve maximal benefit for population health. She is one of the founders of a system to engage patients in systematic reporting of their symptom burden and treatment outcomes that is now recognized by the National Cancer Institute and the FDA. She has led initiatives to link data from state tumor registries, Medicare, Medicaid and electronic health records to improve population health. She collaborates with clinicians, wet and dry lab researchers and public health leaders to measure variation in the effectiveness of cancer treatments and uses this information to prioritize strategies to improve the organization and delivery of cancer care. She leads the Cancer Care Delivery Research program for the Dana-Farber Harvard Cancer Center, is a former board member of the American Society of Clinical Oncology, a member of the American Association of Physicians and an Associate Editor for the Journal of the American Medical Association (JAMA).