Using linked administrative data: Insights and tips from academic clinical trialists

Area of Science:

• Clinical Research
• Health Informatics
• Data Science

Background:

• Investigator-initiated trials increasingly link clinical data with administrative data.
• This approach presents unique challenges and facilitators for trialists.

Purpose of the Study:

• To offer recommendations for assessing the feasibility and suitability of administrative data in clinical trials.
• To guide researchers in navigating the complexities of data linkage.

Main Methods:

• A convergent parallel mixed-methods study surveyed Australian clinical trialists and operations staff.
• Descriptive statistics analyzed survey data; thematic analysis explored in-depth interview data.
• Findings were integrated to provide comprehensive insights.

Main Results:

• Four critical themes emerged: trial management, assessing burdens versus gains, data preparation and analysis, and training and support.
• Key considerations include budgeting, timelines, staffing, operational burdens, consent processes, data linkage, and researcher training.
• Sub-themes highlight the importance of weighing research benefits against operational complexities.

Conclusions:

• Thorough evaluation of administrative data feasibility is crucial, considering costs, skills, timelines, and data accuracy.
• Anticipate delays related to data requests, consent, and access platforms; early planning is essential.
• Health information managers play a vital role in supporting clinical trials using linked administrative data.