Pragmatic Clinical Trials in Dialysis: Addressing Knowledge Gaps in Care

Few randomized clinical trials have been conducted in the dialysis clinic setting due to various perceived barriers – including FDA regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and CMS requirements related to billing for patients involved in research.

The TiME Trial is a large pragmatic clinical trial conducted through the NIH Health Care Systems Research Collaboratory, designed 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 convened a work group of TiME Trial investigators and asked them to assess information about the potential use of pragmatic trials in maintenance dialysis, including operational, regulatory, and business issues that may hinder routine conduct of clinical trials embedded in the provision of clinical care.

The resulting article, Pragmatic Trials in Maintenance Dialysis, has recently been published in JASN.

The Kidney Health Initiative (KHI) promotes much-needed innovation in kidney care. This public private partnership brings together members of the kidney community to overcome obstacles to innovation and identify solutions that will advance kidney care.

 

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Few randomized clinical trials have been conducted in the dialysis clinic setting due to various perceived barriers – including FDA regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and CMS requirements related to billing for patients involved in research.

The TiME Trial is a large pragmatic clinical trial conducted through the NIH Health Care Systems Research Collaboratory, designed 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 convened a work group of TiME Trial investigators and asked them to assess information about the potential use of pragmatic trials in maintenance dialysis, including operational, regulatory, and business issues that may hinder routine conduct of clinical trials embedded in the provision of clinical care.

The resulting article, Pragmatic Trials in Maintenance Dialysis, has recently been published in JASN.

The Kidney Health Initiative (KHI) promotes much-needed innovation in kidney care. This public private partnership brings together members of the kidney community to overcome obstacles to innovation and identify solutions that will advance kidney care.

 

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