Operational determinants of recruitment and biospecimen collection in translational observational studies: a...

Biospecimen collection from study participants is essential for translational research, but operational challenges in study setup and conduct often impede successful delivery. This study uses a comparative approach to explore key logistical and staffing factors influencing setup duration, recruitment efficiency, sample acquisition, and data completeness across three investigator-led microbiome-wide association studies (MWAS) conducted at cancer centres in Ireland.

Three academic observational MWAS enrolling participants with cancers of the breast, gastrointestinal tract, lung, biliary system, kidney, and skin were compared. Data from three cancer centres were analysed. Key variables included study team composition, administrative infrastructure, and full-time equivalent (FTE) research staffing. Metrics assessed included setup duration, recruitment rates, sample acquisition, and data completeness. Descriptive statistics, correlation analyses, and regression models were used to examine relationships between staffing and study performance.

Setup duration ranged from 30 days (Site B, with a pre-established trials unit) to 390 days (Site A, with no dedicated setup personnel). At Site C, the addition of an Academic Clinical Trials Coordinator reduced the remaining setup timeline from 274 to 185 days. Recruitment rates ranged from 1.1 to 1.3 participants/month, with the highest rates at sites with dedicated research nurses (RN +). Sample acquisition was 100% at RN + sites and 70.5% at the RN- site. Site C achieved full data completeness, defined as comprehensive documentation of screening, exclusions, and follow-up outcomes. Statistical modelling suggested that dedicated staffing (both administrative and clinical) was associated with improvements across all metrics, although small sample size limited statistical significance.

Dedicated administrative and clinical trial personnel significantly may enhance study efficiency, participant recruitment, and biospecimen collection in academic translational research. This study provides practical insights for improving study design and infrastructure planning in future observational studies. To our knowledge, this is the first multi-site comparative evaluation of operational determinants in academic MWAS.