PS1-27: Use of Tumor Registry to Obtain Family History Information

Abstract

Background: The Human Genome project has revolutionized the field of medicine to move toward personalized medicine. The family history is a screening tool to identify families at risk for common conditions allowing for personalized care. For breast cancer syndromes, genetic testing, counseling and prophylactic treatment are available. While there are data about the efficacy and clinical utility of the family history, there are areas that still need investigation. Does obtaining the family history lead to patient recommendations? Do patients FDA’s Mini-Sentinel Initiative: The HMORN’s Role. In May 2008, the FDA Commissioner announced FDA’s intention to create the Sentinel Initiative. The Sentinel Initiative is an effort by the FDA to create a coordinated national electronic medical product safety surveillance system. The Food and Drug Administration Amendments Act of 2007 (FDAAA) mandated FDA develop methods to obtain access to disparate data sources and to establish an active post-market risk identification and analysis system linking and analyzing data from multiple sources. The law sets a goal of 25 million patients under surveillance by July 1, 2010, and 100 million patients by July 1, 2012. With the funding and support provided by FDAAA, the FDA laid out the vision for Sentinel Initiative. In September 2009, the FDA awarded a single contract to a consortium of 28 institutions led by the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute, including 13 HMORN members (all Kaiser Permanente plans, Group Health Cooperative, Lovelace Clinic Foundation, Myers Primary Care Institute, Marshfield Clinic Research Foundation, HealthPartners Research Foundation and Henry Ford Health Services), CIGNA, Humana, WellPoint [HealthCore] and Tennessee’s Medicaid system, comprising ~60 million covered lives. Additional data resources include the HMORN’s ambulatory electronic medical records linked to enrollment and claims data for ~10 million patients; inpatient electronic medical records (EMRs), including blood product use from 88 adult and pediatric hospitals (approximately half are Kaiser plans); plus device and disease registries. Mini-Sentinel will create a ‘laboratory’ for developing and evaluating safety surveillance scientific methodologies and offers FDA the opportunity to evaluate safety issues in existing automated healthcare data system(s) while learning about the barriers and challenges inherent in these activities. The collaboration provides FDA with a public-private solution that leverages the strengths of the private sector and academia. Over the next five years, this collaboration will work with FDA to create the foundation for the Sentinel Initiative’s long-term goal of setting up a coordinated national post-market safety surveillance system.