Bridging policy gaps in clinical trial volunteering: public and healthcare professional perspectives in England.

Abstract

Objective: To examine organisational leave policies for clinical trial participation in England and compare willingness between the public and healthcare professionals (HPs) under varying leave conditions.

Methods and analysis: Freedom of information (FOI) requests were submitted to 378 public-sector organisations to identify policies supporting leave for clinical trial participation. Parallel cross-sectional surveys of the public (n=503; working-age adults) and HPs (n=110) assessed willingness to participate as a healthy volunteer (HV) or patient (P) in scenarios requiring annual leave (AL) or unpaid leave (UL). Free-text responses were analysed thematically. Group comparisons used χ² tests, and multivariable logistic regression examined predictors of willingness, adjusting for demographic and employment characteristics.

Results: Five organisations (1.3%) reported an explicit policy addressing clinical trial leave while 336 (88.9%) reported none. Across all scenarios, public respondents were more willing to participate than HPs, particularly for HV participation using AL (78.9% vs 63.6%; p=0.001). In adjusted analyses, HPs had lower odds of willingness than public respondents for HV-AL (aOR 0.52, 95% CI 0.32 to 0.85), P-AL (aOR 0.67, 95% CI 0.44 to 0.98) and P-UL (aOR 0.61, 95% CI 0.38 to 0.96). Willingness declined when UL was required. No association was observed between Index of Multiple Deprivation decile and willingness. Financial concerns were the main barrier among the public, whereas HPs cited limited availability of AL.

Conclusions: There is a widespread lack of organisational policies supporting clinical trial participation leave, and willingness is highly sensitive to whether leave is paid. This is particularly relevant in ophthalmology, where trials often involve repeated, time-intensive visits and reliance on working-age carers. Limitations include non-probability sampling, uncalculated survey response rates, self-reported willingness, a small regionally recruited HP sample and restriction to public-sector FOI data. Employment policy represents an under-recognised structural determinant of clinical trial participation, with implications for ophthalmology research.