Randomised trials (RCT) are a central component of all evidence-informed health care systems.

Evidence coming from RCTs helps to support health care users, health professionals and others to make more informed decisions about treatment. However, RCT evidence available to trialists supporting decisions on design, conduct and reporting of randomised trials is sparse.

Trial Forge (www.trialforge.org) is an initiative that aims to increase the evidence base for trial decisionmaking and, in doing so, to improve trial efficiency.

One way to fill gaps in evidence is to run Studies Within A Trial (SWAT).

The 'Trial Forge Guidance 1: what is a Study Within a Trial (SWAT)' document aims to provide

  • A brief definition of SWATs
  • An explanation of why SWATs are important
  • Some practical top tipsthat come from existing experience of doing SWATs.

The researchers would like this guidance document to be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing a SWAT




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