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Adaptive design methods in dialysis clinical trials: a systematic review protocol
Conor Judge1,2,3,4, Robert P Murphy5, Sarah Cormican3,4
1HRB-Clinical Research Facility, National University of Ireland, Galway, Co. Galway, Ireland conor.judge@nuigalway.ie.
BMJ Open
|August 30, 2020
Summary
This study explores adaptive design methods in dialysis clinical trials. We aim to understand their current use and encourage wider adoption within the nephrology community for more efficient research.
Area of Science:
- Nephrology
- Clinical Trial Methodology
- Biostatistics
Background:
- Adaptive design methods offer potential efficiency gains in clinical trials.
- The current utilization of adaptive designs in dialysis research remains largely unknown.
- The nephrology community's adoption of these advanced trial designs needs investigation.
Purpose of the Study:
- To systematically investigate the application of adaptive design methods in clinical trials focused on dialysis.
- To identify barriers and facilitators for adopting adaptive designs in nephrology research.
- To foster increased use of adaptive designs to enhance dialysis trial efficiency.
Main Methods:
- Systematic literature search using MEDLINE, EMBASE, and CENTRAL databases.
- Data extraction on trial characteristics, adhering to PRISMA and Cochrane guidelines.
- Narrative synthesis of findings, estimating the annual percentage of adaptive dialysis trials.
Main Results:
- Analysis will quantify the prevalence of adaptive designs in dialysis trials.
- Subgroup analyses will explore variations by dialysis modality, funding source, and region.
- Trends in the adoption of adaptive trial methodologies will be presented.
Conclusions:
- Findings will elucidate the current landscape of adaptive designs in dialysis clinical trials.
- The study aims to provide evidence-based recommendations for the nephrology community.
- Promoting adaptive designs can lead to more efficient and effective kidney disease research.
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