Published: 01 March 2023
Version: 1.0 - February 2023Print this document
Randomised controlled trials (RCTs) are a central component of all evidence-informed health care systems but are expensive and time-consuming and often require substantial and sustained commitment from patients and clinical staff. Hence, the evidence to support decisions on design, conduct and reporting of randomised trials is very important. In addition to conducting feasibility studies this evidence can also come from studies within a project (SWAP).
RfPB programme encourages applicants to propose a self-contained research study within a project (SWAP), aimed at improving the successful completion of studies by evaluating alternative ways of delivering or organising a particular trial/project process (e.g. patient/carer/service user recruitment and retention, intervention compliance, data collection, evidence synthesis methodology, public involvement, etc.). It is anticipated that SWAPs will mainly be encountered in Tier 1 applications, while they will be excluded from feasibility study applications. Please note that Tier 3 is still open to standalone methods research providing there is a trajectory to patient/carer/service user benefit.
A SWAP will be a small part of the overall application and should be completed as part of the main study; costed at no more than 15% of total value of the application it needs to be accommodated within the current RfPB funding tier limits.
The findings of SWAPs are expected to be generalisable to other studies but equally may also be of specific benefit to the host trial/project itself, by supporting trial delivery process decision points. The study would be short and efficient, and we would expect its findings to be published.
Stage 1 applications should indicate if they intend to include a SWAP in their study, however a detailed description of the SWAP is not required until Stage 2.
Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?