What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study

Abstract

ObjectivesEarly phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.DesignSemistructured interview study.SettingPatients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.ParticipantsThirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.MethodsInterview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.ResultsMost patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.ConclusionsThis novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.

Why trials lose participants: A multitrial investigation of participants’ perspectives using the theoretical domains framework

“…One common approach used to apply behavior change theory within health research is the Theoretical Domains Framework (TDF-see Box 1 for domains and definitions) [7 , 8] . Recent interview studies have utilized the TDF to explore barriers and enablers to enacting behaviors within clinical trials, such as intervention delivery and participant recruitment [9][10][11] . However, the TDF has not previously been used to identify barriers and enablers to retention in trials from the perspectives of trial participants [12] .…”

Behavioural Optimisation To Address Trial Conduct Challenges: Case Study In The UK-REBOA Trial

“…A recent qualitative study explored clinician reported challenges to recruitment in trials set within emergency care and identi ed a range of in uential factors, including: supporting the patients to engage with the research, issues around equipoise, surgeon preferences, interpretation of eligibility criteria, and balance of clinical vs. research roles (8). In addition, other recent studies have incorporated behavioural frameworks to identify challenges for trial recruitment and intervention delivery (3,4,10,11). However, the majority of these existing studies do not go as far as developing potential solutions and implementing them within the trial to proactively address the challenges identi ed.…”

“…Identifying the behavioural in uences of core trial processes (and optimising them where improvements are needed) could help contribute to understanding the overall success or failure of the trial. Behavioural approaches to understand and change trial process behaviours are starting to emerge in the literature, but to date have largely focussed on identifying behavioural problems for trial recruitment and retention (3)(4)(5)(6). The applicability of a behavioural science approach to both identify trial process barriers and implement strategies to address these challenges warrants further attention.…”

“…By applying a behavioural science lens to explore problematic processes in trial conduct within the UK-REBOA trial, questions about who needs to do what differently, to whom, when and how followed by the application of these theory-informed ndings to develop evidence-based solutions were facilitated. Recent studies have highlighted the utility of the Theoretical Domains Framework (TDF) to identify processes where the performance could be improved within clinical trials, and we therefore chose to apply this framework in our study (3)(4)(5)10,11). Application of the TDF also provides an opportunity to develop evidence-based behavioural interventions that can foster positive changes, and as such has potential to help improve the effectiveness and delivery of trial processes (12).…”

Review article: randomised controlled trials in inflammatory bowel disease—common challenges and potential solutions

“…A lack of time on the part of physicians, both for the identification of ongoing trials and the patients that would be suitable for inclusion, is another major hurdle to trial recruitment. [79][80][81] Reducing the administrative burden on physicians would allow them to more efficiently screen patients and perform clinical trial duties.…”