Real-world data to improve Organ and Tissue Donation Policies: Lessons learned from the Tissue and Organ Donor Epidemiology Study

Abstract Background: The transplantation of human organs, and some human tissues, is often the only life-saving therapy available for serious and life-threatening congenital, inherited, or acquired diseases. However, it is associated with a risk of transmission of communicable diseases from donor to recipient. It is imperative to understand the characteristics of the donor population to inform policies that protect recipient safety. The Tissue and Organ Donor Epidemiology Study (TODES) was a pilot project designed to identify and collect standardized information on deceased persons referred for organ, tissue, and/or eye donation, and to estimate (to the extent possible) infectious disease prevalence and incidence of HIV, HBV, and/or HCV in this population. TODES is summarized here to shed light on addressable limitations on accessing data needed for transplant recipient safety. Limitations, future research needs, and potential pathways to solve the remaining data needs are explored. Methods: Retrospective data for all deceased donors during a 5-year period from 2009 to 2013 were obtained from participating organ procurement organizations (OPOs), tissue establishments, and eye banks. These decedent data on actual donors and potential donors were used to ascertain whether the available real-world data (RWD) could be used to inform donor screening and testing policy. Results: The TODES database contains 291,848 records received from nine OPOs and 42,451 records received from four eye banks. Data were analyzed from deceased donors with at least one organ, tissue, or ocular tissue recovered with the intent to transplant. Results for potential donors were not analyzed. Available RWD at the time of the TODES study were not fit-for-purpose to help characterize the organ- and tissue eye donor populations and/or to inform donor screening policy. Conclusions: Recent advances in electronic data collection systems make it more realistic to now collect fit-for-purpose RWD that address the research needed to improve transplant safety.