Health Inf Manag. 2026 Jan 31:18333583251413652. doi: 10.1177/18333583251413652. Online ahead of print.
ABSTRACT
BACKGROUND: This study shares insights from clinical trialists who have conducted investigator-initiated trials that have linked trial data to administrative data, focusing on the challenges and facilitators of this approach.
OBJECTIVE: To provide recommendations for evaluating the feasibility and suitability of using administrative data in clinical trials.
METHOD: A convergent parallel mixed-methods study was conducted, surveying Australian clinical trialists and operations staff. Participants could opt-in to in-depth interviews. Survey data were analysed using descriptive statistics, while thematic analysis was applied to interview data, with findings integrated during interpretation.
RESULTS: Four main themes and 10 sub-themes were identified as critical when evaluating the suitability of administrative data for clinical trials: (i) “trial management considerations” covers operational factors like budgeting, timelines and staffing; (ii) “assessing burdens vs. gains” encourages weighing up the research benefits with the additional operational and consent considerations; (iii) “data preparation and analysis” addresses the processes involved in preparing and analysing data for linkage between trial and administrative datasets; and (iv) “training and support” emphasises the need for researcher support when using linked data.
CONCLUSION: Researchers should carefully evaluate the feasibility of using administrative data, considering costs, required skills, timelines and data accuracy. They must also be prepared for delays due to data request processes, participant consent requirements and the mandated use of data access platforms. Early planning can mitigate later complexities.Implications for health information management practice:This study highlights the value of health information managers in clinical research, particularly in managing electronic health records and clinical coding. Their expertise in these areas, as well as in data governance and system architecture, can support clinical trials that link to administrative data.
PMID:41618687 | DOI:10.1177/18333583251413652
