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Validity of Renal Transplant Outcomes in the Australian and New Zealand Dialysis and Transplant Registry: Comparison with Clinical Trials Data
Proposal
10204
Title of Proposed Research
Validity of Renal Transplant Outcomes in the Australian and New Zealand Dialysis and Transplant Registry: Comparison with Clinical Trials Data
Lead Researcher
Tracey Ying
Affiliation
Employer: Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia Research Affiliation: University of Sydney, Sydney, NSW, Australia
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
24 June 2020
Lay Summary
The Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) routinely collects important information about what happens to people with kidney transplants. The ANZDATA registry is an important research tool to help clinicians improve practice with an aim to improve patient care. The accuracy of the data obtained by the registry is unclear and requires assessment.Kidney transplant recipients often enter clinical trials, which provides top quality data for evidence-based medicine. Strategies and interventions such as standard operating procedures, personnel training, and data monitoring are implemented in clinical trials to reduce error. International and national guidelines also stipulate for data quality and assurance. Thus, clinical outcomes captured in clinical trials is universally accepted as the gold-standard.To assess the accuracy of the ANZDATA registry for important outcomes such as kidney survival, the aim of this study is to compare the outcomes collected by the ANZDATA registry to the outcomes collected by patients enrolled in a clinical trial.
Study Data Provided
[{ "PostingID": 4137, "Title": "NOVARTIS-CRAD001A2309", "Description": "Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients" },{ "PostingID": 19847, "Title": "NOVARTIS-CRAD001A2433", "Description": "A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation" }]
Statistical Analysis Plan
Publication Citation
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