Researchers' perspectives of accessing healthcare systems data for use in randomised controlled trials

OBJECTIVES: Identify the key challenges and opportunities researchers face when accessing healthcare systems data (HSD) for randomised controlled trials (RCTs) and develop a consolidated set of recommended improvements. METHODS: Multidisciplinary researchers with expertize in RCTs were invited to participate in online focus groups and individual interviews to share their experiences of accessing HSD. Data were analyzed using directed content analysis guided by themes identified in prior research. RESULTS: Three distinct stages of the HSD access process were identified, covering preparation, submission of a data access application to a provider, and working with the received data, each presenting specific challenges and opportunities for improvement. In the preapplication stage, participants highlighted limited awareness and experience with HSD and emphasized the need for clearer guidance. During the data access application stage, researchers described difficulties related to the mismatch between application requirements and the needs of RCTs, as well as delays in progression. In the postapplication stage, challenges in receiving and working with the data were reported, alongside recognition of the tangible benefits that HSD can provide for trial delivery and quality. CONCLUSION: Identifying challenges across the HSD access process can help trial teams anticipate potential obstacles and plan more effectively. Given that the current application process does not fully meet the needs of RCTs, the recommendations derived from this work highlight key areas for improvement that providers could implement to reduce barriers and better support the use of HSD in trials.