TY - JOUR AU - Naesens, Maarten AU - Schneeberger, Stefan AU - , the ESOT Working Group AU - Naesens, Maarten AU - Ulrich Becker, Jan AU - Irene Bellini, Maria AU - Bestard, Oriol AU - Böhmig, Georg A. AU - Budde, Klemens AU - Caskey, Fergus AU - Claas, Frans AU - Couzi, Lionel AU - Diekmann, Fritz AU - Dobbels, Fabienne AU - Furian, Lucrezia AU - Glotz, Denis AU - Grinyó, Josep AU - Heemann, Uwe AU - Hesselink, Dennis AU - Hilbrands, Luuk AU - Jochmans, Ina AU - Loupy, Alexandre AU - Mamode, Nizam AU - Oberbauer, Rainer AU - Pengel, Liset AU - Rabant, Marion AU - Reinders, Marlies AU - Rostaing, Lionel AU - Roufosse, Candice AU - Schneeberger, Stefan AU - Seron, Daniel AU - Thaunat, Olivier AU - Tong, Allison PY - 2022 M3 - Executive Summary TI - Redefining Risk Stratification and Endpoints for Clinical Trials in Kidney Transplantation: Rationale and Methodology of Proposals Submitted to the European Medicines Agency by the European Society for Organ Transplantation JO - Transplant International UR - https://www.frontierspartnerships.org/articles/10.3389/ti.2021.10142 VL - 35 SN - 1432-2277 N2 - The European Society for Organ Transplantation (ESOT) submitted a Broad Scientific Advice request to the European Medicines Agency (EMA) in 2018, to explore whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research, thereby improving long-term outcomes for allograft recipients. The request was refined collaboratively by the EMA and ESOT, with the EMA issuing a final response in December 2020. This Transplant International special issue explores the topics that were the focus of these interactions between the EMA and ESOT. Articles explore the current issues and dilemmas in kidney transplantation, primarily relating to unclear or outdated risk stratification and markers of transplantation success, although several potential improvements for outcomes assessment are also suggested. Discussions between the EMA and ESOT and recommendations are summarized, in the hope that this project will generate further discussion eventually generating a consensus on clinical trial endpoints and risk stratification, increase the quality of research in transplantation medicine, and improve long-term outcomes for kidney transplant recipients. ER -