Principal Investigator(s):
Dr Evelyne Kestelyn (Chief PI)
Dr. Suchita Shrestha ((OUCRU Nepal, Country PI)
Funder(s): A3CT (Wellcome trust)
Location(s): Nepal, Vietnam, Indonesia
Duration: October 2024 to December 2027
Studies Within A Trial (SWATs) are self-contained studies embedded within a host trial to evaluate alternative ways of improving trial processes. Although SWATs have been widely developed and conducted in the UK, they remain a relatively new concept in low- and middle-income countries (LMICs). As the number of clinical trials conducted in LMICs continues to grow, these settings may particularly benefit from SWATs, since the challenges of implementing trials often differ from those in high-income countries. However, there is currently limited evidence on how trial processes have been evaluated in LMICs or whether strategies similar to SWATs have been used to improve them.
This study aims to explore the acceptability of SWATs and identify the needs and priorities for their implementation among clinical trial stakeholders in Vietnam, Nepal, and Indonesia. The study will be conducted in four stages. First, a literature review will identify existing SWATs or SWAT-like studies conducted in LMICs, examining the approaches used, outcomes assessed, and implementation challenges reported. Second, educational materials will be developed to introduce the concept of SWATs to stakeholders in the three countries. Third, qualitative interviews and focus group discussions will explore stakeholders’ perceptions of SWATs, including their feasibility, ethical considerations, and perceived burden. Finally, a quantitative survey will assess stakeholder priorities and needs related to the implementation of SWATs in these settings.
