Clinical Trial Participation: A Pilot Study of Patient-Identified Barriers

Abstract

Background: Little progress has been made in the past decade on improving clinical trial enrollment in the United States, particularly for adults and those in ethnic and racial minorities. Oncology nurses play a pivotal role in identifying and addressing patient concerns about clinical trials. Objectives: The aim was to identify patient-related barriers to clinical trial participation using a mixed-method patient survey and offer insights to develop evidence-based implementation strategies to address these barriers. Methods: A retrospective survey was conducted of patients who were not interested in participating in a clinical trial to quantify the reasons these patients chose not to participate. Directed qualitative content analysis was used to identify themes that emerged from the write-in responses. Findings: The greatest patient-reported barriers were misperceptions about placebos, not wanting to feel like a ‘human guinea pig’, uncertainty surrounding clinical trial treatment effectiveness compared to standard care, and concerns about additional appointments or tests. Oncology nurses can address patient enrollment barriers by providing targeted education and participating in the informed consent process.

Benefits of Participation in Clinical Trials: An Umbrella Review

“…A patient and public involvement (PPI) approach to the trial development process, from the formulation of research questions to the dissemination of results, may help staff build trusting relationships with potential participants and foster mutual commitment [ 14 , 15 ]. If it can be demonstrated that participating in RCTs improves health status, this would encourage volunteers to take part in research and enable health professionals to be confident about inviting patients to engage in trials [ 16 , 17 ]. Evidence regarding the benefits of participating in RCTs may help to interpret the generalisability of research findings, aiding in the implementation of new interventions in clinical practice and healthcare policy [ 18 ].…”

Primary care patient interest in joining a planned multi‐cancer early detection clinical trial

“…McKinney and colleagues, as well as others, have suggested that the need for ancillary support to help clinicians identify patients who are eligible for clinical trials and educate eligible patients about trial procedures. [44][45][46] Such support is integral not only for ensuring patient engagement and education, but also to facilitate enrollment. Findings reported here highlight the value of persons who can provide ancillary support to clinicians for identifying patients who are eligible for clinical trials and in educating eligible patients about trial procedures as part of the enrollment process.…”

“…Of the patients who were reached, over a third agreed to participate in the current research study, and most study participants expressed interest in joining the trial. McKinney and colleagues, as well as others, have suggested that the need for ancillary support to help clinicians identify patients who are eligible for clinical trials and educate eligible patients about trial procedures 44–46 . Such support is integral not only for ensuring patient engagement and education, but also to facilitate enrollment.…”

Patient engagement and satisfaction with early phase cell therapy clinical trials at a tertiary inflammatory bowel disease center

“…The survey demonstrated that one of the greatest challenges for patients was the cost of travel and time away from work. Prior studies have cited concerns related to ambiguity of treatment effectiveness, fear of adverse events, lack of control of treatment versus placebo, and time required for participation as major factors that impacted the decision to participate in a trial ( Brown, et al., 2013 ; McKinney et al., 2021 ). There was consistent messaging from patients that time away from work and overall cost remain a significant challenge.…”