Barriers to Clinical Trial Implementation Among Community Care Centers

Key Points

Question

What are the most common barriers to clinical trial implementation among community cancer centers, and what strategies might overcome them?

Findings

This survey study assessed 58 cancer centers across 25 states. While most centers (88%) offered therapeutic oncology trials, considerable disparities were observed between different care settings, such as fewer industry-sponsored trials at practices with smaller patient volumes and fewer early-phase trials among rural and suburban practices.

Meaning

These findings indicate that community cancer centers face unique challenges to engaging in clinical trials; support is needed from pharmaceutical companies, health care policymakers, national advocacy groups, and investigators to devise targeted interventions that improve access among these centers and enhance equity across all practice settings.

Abstract

This survey study investigates critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment.

Abstract

Importance

While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol.

Objective

To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment.

Design, Setting, and Participants

This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)–ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents. To determine participation trends among health care practices in oncology-focused research, identify barriers to clinical trial implementation and operation, and establish unmet needs for cancer clinics interested in trial participation, a 34-question survey was designed. Survey questions were defined within 3 categories: cancer center demographic characteristics, clinical trial characteristics, and referral practices. The survey was distributed through email and was open from June 20 through October 5, 2022.

Main Outcomes and Measures

Participation in and barriers to conducting oncology trials in different community oncology settings.

Results

The survey was distributed to 100 cancer centers, with completion by 58 centers (58%) across 25 states. Fifty-two centers (88%) reported that they conduct therapeutic clinical trials, of which 33 (63%) were from urban settings, 11 (21%) were from suburban settings, and 8 (15%) were from rural settings. Only 25% of rural practices (2 of 8) offered phase 1 trials, compared with 67% of urban practices (22 of 33) ( P = .01). Respondents noted challenges in conducting research, including patient recruitment (27 respondents [52%]), limited staffing (27 [52%]), and nonrelevant trials for their patient population (25 [48%]). Among sites not offering therapeutic trials, barriers to research conduct included limited infrastructure, funding, and staffing. Most centers (46 of 58 [79%]) referred patients to outside centers for clinical trial enrollment, particularly in the context of late-stage disease and/or disease progression. Only 17 of these sites (37%) had established protocols for patient follow-up subsequent to outside referral.

Conclusions and Relevance

In this national survey study of barriers to clinical trial implementation, most sites offered therapeutic trials, but there were significant disparities in trial availability across care settings. Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities. These results identify crucial unmet needs for oncology clinics to effectively offer clinical trials to patients seeking care.