Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Area of Science:

• Clinical Trials Methodology
• Health Services Research
• Evidence-Based Medicine

Background:

• Randomised trials are fundamental to evidence-informed healthcare, yet decision-making regarding their design, conduct, and reporting relies on limited evidence.
• The Trial Forge initiative aims to bolster the evidence base for trial-related decisions, thereby enhancing overall trial efficiency.
• Studies Within A Trial (SWATs) represent a key strategy for generating this evidence and addressing knowledge gaps.

Discussion:

• This guidance document defines SWATs, elucidates their importance in improving trial efficiency, and offers practical 'top tips' derived from existing experience.
• SWATs facilitate the systematic evaluation of different trial components within the framework of a larger trial.
• The document aims to clarify the concept and practicalities of conducting SWATs for various stakeholders.

Key Insights:

• SWATs provide a structured methodology for generating evidence to optimize the design, conduct, and reporting of randomised trials.
• Implementing SWATs can lead to more efficient and effective clinical trials, ultimately improving healthcare outcomes.
• Practical guidance and 'top tips' are essential for the successful execution of SWATs.

Outlook:

• Widespread adoption of SWATs, supported by clear guidance, can significantly advance the science of conducting clinical trials.
• This initiative holds the potential to improve the quality and efficiency of evidence generation for healthcare decision-making.
• Further development and dissemination of best practices for SWATs are anticipated to benefit trialists, methodologists, and funders alike.