KHI Workgroup Opportunity

Pragmatic Trials in Dialysis: Challenges and Opportunities

Overview

Defining the benefit of a therapy in routine clinical experience is an important opportunity for kidney diseases. 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.

The TiME Trial was a large pragmatic clinical trial 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 was 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. The Kidney Health Initiative supported a workgroup comprised of TiME Trial investigators to provide the kidney community with information about the potential use of pragmatic trials to answer important clinical questions. In addition, the working group was tasked with recommending solutions to operational, regulatory, and business issues that may hinder routine conduct of clinical trials embedded in the provision of clinical care.

Deliverable

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative

Pragmatic Clinical Trials in CKD: Opportunities and Challenges