June 10, 2016: Pragmatic Trials in Dialysis
Pragmatic Trials in Dialysis: What’s Next After the TiME Trial?
Laura Dember, MD, University of Pennsylvania
TiME; end-stage renal disease; dialysis; Time to Reduce Mortality in End-Stage Renal Disease; pragmatic clinical trials; hemodialysis
- Dialysis-dependent end-stage renal disease has a high mortality rate, and there are many unanswered questions about fundamental aspects of dialysis care. Dialysis is well-suited for studying in pragmatic trials, because the infrastructure of dialysis provider organizations allows highly centralized trial implementation.
- Ideas for potential future dialysis trials were explored; research questions included dialysis solution potassium concentration, serum phosphorus target, and type of phosphate binder.
- Experience gained through the TiME trial highlights important successes and challenges that should inform future pragmatic trials in dialysis. Implementing the trial intervention required ongoing buy-in and support at many levels (e.g., corporate leadership, administrators, facility staff, facility nephrologists, patients). Regulatory uncertainties and barriers also must be overcome; however, the challenges should not be viewed as prohibitive to conducting these important studies.
The interrelated barriers of minimal risk and FDA oversight were discussed for this type of research.
Could the proposed research questions on dialysis be addressed in a parallel fashion to get answers faster?
What is the payment model for this type of dialysis research—are dialysis centers interested in funding it?
What, if any, barriers are there in working with the large dialysis systems?
For More Information
Learn more about the TiME Trial.
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