Pragmatic Trials in Dialysis: Challenges and Opportunities
Patient Care Issue
Defining the benefit of a therapy in routine clinical experience is an important opportunity for kidney diseases. There are almost 400,000 hemodialysis patients in the United States. This patient population has a mortality rate approaching 50% at three years from the start of hemodialysis, incurring Medicare expenditures in excess of $24 billion annually.
The TiME Trial is a large pragmatic clinical trial that is being conducted through the NIH Health Care Systems Research Collaboratory, a Common Fund initiative that aims to integrate clinical trials into healthcare delivery. The objective of the trial is to determine whether dialysis facility implementation of a hemodialysis session duration of at least 4.25 hours for incident patients improves clinical outcomes and quality of life.
Few randomized clinical trials have been conducted in this setting due to various perceived barriers – including US Food and Drug Administration (FDA) regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and cumbersome Centers for Medicare and Medicaid Services requirements related to billing for patients involved in research.
KHI is supporting a workgroup comprised of TiME Trial investigators. The goal of the project is to provide the kidney community with information about the potential use of pragmatic trials to answer important clinical questions. In addition, the workgroup will recommend solutions to operational, regulatory, and business issues that may hinder routine conduct of clinical trials embedded in the provision of clinical care.