The Challenge of Enrolment in Clinical Trials – Can Patients Help Design Better trials? скачать в хорошем качестве

The Challenge of Enrolment in Clinical Trials – Can Patients Help Design Better trials?

Nick Bansback, PHD Program Head – Decision Sciences, Advancing Health Professor, School of Population and Public Health, UBC Program Director, Master of Health Administration, School of Population and Public Health, UBC Alex Tam, MSc Research Project Manager, Advancing Health Failing to recruit in a clinical trial is costly, reduces the trial’s ability to answer the intended research question, and it risks unnecessary exposure to study interventions. International evidence suggests various trial-level aspects affect recruitment, including non-design (e.g., sponsor/funder) and design (e.g., eligibility criteria) factors. In this presentation, we will first describe a review of clinical trials conducted in Canada registered on ClinicalTrials.gov to find the proportion of Canadian trials that fail to meet their intended recruitment targets. Associations between trial design and recruitment success from logistic regression will be explored. We will then describe a prospective study that was undertaken to inform trial design by considering the voices of the patients who would be eligible for enrolment. In this study we listened to people with ACL injury, to understand how different trial designs might attract or detract them to participate in a clinical trial of an intervention which might reduce the risk of post traumatic osteoarthritis (PTOA). We describe the focus groups which were followed by an online survey employing a discrete choice experiment (DCE) in patients with ACL injury who met eligibility for a proposed clinical trial. The survey included information about the potential interventions for PTOA, and described modifiable aspects of the clinical trial. The DCE questions asked respondents to trade-off between specific design features that emerged from the focus groups that might influence enrolment (proposed effect size, type and magnitude of side-effects, who invites participation, end of trial options, rate of compensation, other benefits, distance to study visits and inclusiveness of material and staff). Mixed logit and latent class analysis was used to explore relative preferences for enrolment and how preferences varied across respondents.