Abstract
BackgroundHigh patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients’ willingness to participate in research.MethodsWe submitted by mail two vignettes that described clinical research studies – a drug trial and a diagnostic study – to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on request.ResultsOf 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% vs. 76.2%; P < 0.001). In the drug trial, participation was significantly higher when the new drug was presented as presumably better than the old (vs. equipoise) and when the study was funded by public sources (vs. industry), but was not affected by the allocation method. None of the factors tested in the diagnostic study was associated with participation.ConclusionsPatients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed and when the trial was funded by industry. These results suggest that some features of study design can influence participation.
Highlights
High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings
Low participation rates may lead to selection bias and impede the generalizability of study findings drawn from non
Excellent or very good self-rated health status was independently associated with a higher participation compared to good/fair/poor health status. In this experimental study conducted among patients discharged from hospital, willingness to participate in hypothetical studies was lower for a trial assessing the efficacy of a new drug than for an observational study testing the performance of a new diagnostic tool
Summary
High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients’ willingness to participate in research. Methods: We submitted by mail two vignettes that described clinical research studies – a drug trial and a diagnostic study – to patients recently discharged from hospital and assessed their willingness to participate. Several studies have explored the factors associated with patient participation in clinical trials. Gayet-Ageron et al BMC Medical Research Methodology (2020) 20:93 personal benefits from participation in cancer trials for example [4,5,6], but participation was not associated with tumor stage/type, age or gender [7]. Among factors related to the study design and logistics, prior approval from an ethics committee [8] and public release of results [9] were associated with greater participation, but random allocation of interventions [10, 11], placebo use [12, 13], complex or inadequate study information [14], and personal inconvenience (e.g. extra appointments, burden of intervention) [12] were associated with lower participation
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