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Updated: Sep 20, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Patient-centred clinical trial design
Allison Tong1,2, Nicole Scholes-Robertson3,4, Carmel Hawley5,6
1Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. Allison.tong@sydney.edu.au.
Abstract:
Patient involvement in clinical trial design can facilitate the recruitment and retention of participants as well as potentially increase the uptake of the tested intervention and the impact of the findings on patient outcomes. Despite these benefits, patients still have very limited involvement in designing and conducting trials in nephrology. Many trials do not address research questions and outcomes that are important to patients, including patient-reported outcomes that reflect how patients feel and function. This limitation can undermine the relevance, reliability and value of trial-based evidence for decision-making in clinical practice and health policy. However, efforts to involve patients with kidney disease are increasing across all stages of the trial process from priority setting, to study design (including selection of outcomes and approaches to improve participant recruitment and retention) and dissemination and implementation of the findings. Harnessing the patient voice in designing trials can ensure that efforts and resources are directed towards patient-centred trials that address the needs, concerns and priorities of patients living with kidney disease with the aim of achieving transformative improvements in care and outcomes.
Insights
Patient involvement in clinical trial design is crucial for kidney disease research. Engaging patients ensures trials address their needs, improving outcomes and research relevance.
Area of Science:
- Nephrology
- Clinical Trials
- Patient-Centered Research
Background:
- Patient involvement in clinical trial design offers benefits like improved recruitment, retention, and intervention uptake.
- Currently, patient involvement in nephrology trial design is limited, often neglecting patient-important research questions and outcomes.
- This lack of patient input can reduce the relevance and value of trial evidence for clinical practice and health policy.
Purpose of the Study:
- To highlight the importance of patient involvement in nephrology clinical trial design.
- To advocate for increased patient engagement throughout the trial process.
- To emphasize the potential for patient-centered trials to improve care and outcomes for individuals with kidney disease.
Main Methods:
- Literature review and synthesis of current practices in clinical trial design.
- Analysis of the impact of patient involvement on trial outcomes.
- Identification of strategies to enhance patient engagement in nephrology research.
Main Results:
- Patient-centered trials are more likely to address relevant research questions and patient-reported outcomes.
- Increased patient involvement can enhance participant recruitment and retention rates.
- Integrating patient perspectives ensures trial findings are valuable for decision-making.
Conclusions:
- Actively involving patients in all stages of clinical trial design is essential for nephrology research.
- Harnessing the patient voice leads to more relevant, reliable, and impactful trial evidence.
- Patient-centered trials have the potential to drive transformative improvements in kidney disease care and patient outcomes.
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