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Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs)
Hanne Bruhn1,2,3, Shaun Treweek3, Charles Weijer4
1Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Trials
|August 3, 2025
Summary
Studies Within A Trial (SWATs) improve clinical trial processes but face varying ethical standards. This study developed guidance to ensure ethical conduct and address implementation differences in SWATs for better trial management.
Area of Science:
- Clinical Trials Methodology
- Research Ethics
- Health Services Research
Background:
- Randomised trials encounter challenges in recruitment, retention, and delays, impacting finances and patient care.
- Studies Within A Trial (SWATs) are embedded research studies designed to evaluate alternative trial processes.
- Variations in SWAT implementation, including consent requirements, necessitate standardized ethical approaches.
Framework:
- Developed guidance addressing 14 ethical considerations for randomised SWATs.
- Considerations cover all SWAT stages, from development and team selection to results communication.
- Guidance is presented as actionable questions for trial teams designing SWATs.
Implementation:
- Systematic reviews, literature searches, and SWAT register exploration identified relevant SWATs.
- Information on SWAT descriptives and 19 potential ethical outcomes was extracted.
- Three consensus-building fora with diverse stakeholders refined ethical principles, challenges, and solutions.
Implications:
- SWATs are generally low risk, but ethical standards vary among researchers, sponsors, and ethics committees.
- The developed guidelines aid in understanding ethical differences and implications in SWATs.
- Provides a practical framework for the ethical conduct and review of SWATs.
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