TY - T1 - Demonstrating Benefit-Risk Profiles of Novel Therapeutic Strategies in Kidney Transplantation : Opportunities and Challenges of Real-World Evidence SN - / UR - http://hdl.handle.net/10138/346519 T3 - A1 - Helanterä, Ilkka; Snyder, Jon; asberg, Anders; Cruzado, Josep Maria; Bell, Samira; Legendre, Christophe; Tedesco-Silva, Helio; Barcelos, Giovanna Tedesco; Geissbuehler, Yvonne; Prieto, Luis; Christian, Jennifer B.; Scalfaro, Erik; Dreyer, Nancy A. A2 - PB - Y1 - 2022 LA - eng AB - While great progress has been made in transplantation medicine, long-term graft failure and serious side effects still pose a challenge in kidney transplantation. Effective and safe long-term treatments are needed. Therefore, evidence of the lasting benefit-risk of novel therapies is required. Demonstrating superiority of novel therapies is unlikely via conventional randomized controlled trials, as long-term follow-up in large sample sizes pose statistical and operational challenges. Furthermore... VO - IS - SP - OP - KW - data harmonization; extension studies; real-world evidence; registries; kidney transplantation; END-POINTS; FOLLOW-UP; RECIPIENTS; IMMUNOSUPPRESSION; INTERVENTIONS; CHECKLIST; CONSENSUS; OUTCOMES; TRIALS; 3126 Surgery, anesthesiology, intensive care, radiology N1 - PP - ER -