Background: Regulatory commitments to monitor long-term outcomes such as cancer are increasing in both the US and Europe. Linking data from patients exposed to a medication of interest with cancer registries is one approach to monitoring for potential signals. The ongoing Forteo Patient Registry, initiated in 2009, can provide insights for patient recruitment and cancer registry link-ages.
Objectives: To describe patient recruitment methods, cancer registry linkage status, and progress of the voluntary Forteo Patient Registry, designed to estimate the incidence of osteosarcoma in patients who have received treatment with Forteo.
Methods: Patient enrollment is tracked quarterly by method of recruitment (i.e., where patient obtained enrollment form). For 12 years, an annual linkage will be per-formed by all participating state cancer registries using a standardized linkage algorithm with the Forteo Patient Registry database. Linkage variables include name, birth date, sex, address, telephone number, race, ethnicity, and last 4 digits of social security number.
Results: As of December 2011, a total of 22,105 US patients were registered. The distribution by method of recruitment was medication packaging (63%), starter kit(24%), study toll-free number (6%), physician tear pad(2%), patient brochure (2%),direct pharmacy mail (2%),and study website (1%). In September 2011, a total of 37state cancer registries covering 85% of the US population participated in the second annual linkage, linking 16,365patients from the Forteo Patient Registry with 961 adult osteosarcoma cases diagnosed since January 1, 2009. No matches among Forteo users were identified.
Conclusions: Including information about this voluntary patient registry in product packaging has been the most frequent pathway for patient recruitment to date. Linking with a large proportion of US state cancer registries is feasible but requires significant effort and resources on the part of the researchers and cooperation by multiple individuals at each participating cancer registry.
