Missing Link for HEOR: A Path Forward for HEOR Data Integration

Speaker(s)

Nancy A Dreyer, MPH, PhD, FISPE, Dreyer Strategies LLC; University of North Carolina at Chapel Hill; Picnic Health, Newton, MA, USA, Keri Monda, PhD, Amgen Inc, Thousand Oaks, CA, USA, Joe Franklin, JD, PhD, Verily, Washington, DC, USA, Niall Brennan, MPP, CDC, Atlanta, GA, USA and Steven Farmer, MD, PhD, Centers for Medicare & Medicaid Services, Baltimore, MD, USA

The integration and linkage of real-world data allows assembly of the whole picture of how patients feel by supporting incorporation of patient-generated health data with clinical data from electronic medical records and study-specific case report forms, and payer information through linkage of pharmacy and other health insurance claims. Data linkage may even extend beyond health care facilitates to include information about school attendance and other community data. In addition to incorporating patients’ experience to understand medical product safety, tolerability and effectiveness, linkage to health systems facilitates long term follow-up of medical products like cell and gene therapies and can also be used to evaluate delayed safety and risks. However, the process of linkage and integration is far from straight forward. Privacy constraints limit what and how much data can be shared, and the linkage process itself involves many assumptions to determine accurate matches from often-incomplete personal identifier information. We are about to learn a lot more about how well these linkages work since the FDA has asked to receive information establishing the accuracy of any linkage before linked data can be used for regulatory submissions. Come join this lively discussion with seasoned experts about the vision, key issues and reasons for optimism.

Code

200

Topic

Real World Data & Information Systems