October 11, 2023 Applying propensity methods to the United States transplant registry for external real-world evidence control arms for 5-year survival in the BENEFIT study To address the challenges of assessing the impact of a reasonably likely surrogate endpoint on long-term graft survival....
September 25, 2023 Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant.
September 25, 2023 Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant.
July 25, 2023 Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development
July 25, 2023 Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation Kidney transplantation is the preferred treatment for individuals with end-stage kidney disease. From a modeling perspective...
July 20, 2023 Acute Rejection After Kidney Transplant—An Endpoint Not Predictive of Treatment Effect on Graft Survival
July 13, 2023 Diagnostic capacities and treatment practices on implantation mycoses: Results from the 2022 WHO global online survey Between January and March 2022, WHO conducted a global online survey to collect data on diagnostic capacities and treatment...
June 12, 2023 Fosfomycin for Non-Urinary Tract Infections: a systematic review Although fosfomycin is currently approved for treating urinary tract infections, it is increasingly being used as salvage...
June 7, 2023-June 8, 2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Panel within a virtual workshop presented by The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.
May 4, 2023 A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools COVID-19 highlighted the need for use of real-world data (RWD) in critical care as a near real-time resource for clinical...