Patient and Caregiver Reported Barriers to Cancer Clinical Trial Participation: A Scoping Review

Abstract

Background

The development of cancer treatments relies on patient participation in clinical trials, yet poor recruitment and retention hinder evidence generation. There exists an urgent need for trial designs that address patient-identified barriers, informational gaps, and concerns. The goal of this evidence synthesis was to identify patient- and caregiver-reported barriers to trial participation and retention.

Methods

We conducted a search in PubMed, Ovid MEDLINE, CINAHL Complete, Scopus, and Web of Science to identify studies describing patient- and caregiver-reported barriers to cancer clinical trial participation. Eligible studies included qualitative or quantitative research published in the English language that reported barriers experienced by individuals with cancer or their caregivers. Four authors screened titles and abstracts, followed by full-text review and data abstraction of included studies. Qualitative results were summarized narratively, and quantitative findings were described using descriptive statistics. Barriers and recommendations for improved clinical trial design were categorized into thematic groups.

Results

The search yielded 7918 studies, with 131 meeting inclusion criteria. Barriers to trial participation were grouped into three overarching themes: (1) psychosocial barriers (e.g., fear of adverse events, distrust, and perceived limited personal benefit); (2) logistical barriers (e.g., travel requirements and financial burden); and (3) informational barriers (e.g., challenges understanding consent materials). Recommendations emphasized financial and logistical support for participants, appropriate information provision, and fostering trust between patients and trial staff.

Conclusion

Addressing informational, psychosocial, and logistical obstacles to participation is essential for timely evidence generation. Without meaningful strategies to engage patients and caregivers in clinical trial designs, evidence generation for novel oncology innovations will continue to lag, hampering patient access and appropriate reimbursement.