Increasing Minority Enrollment Onto Clinical Trials: Practical Strategies and Challenges Emerge From the NRG Oncology Accrual Workshop

Abstract

Racial and ethnic diversity has historically been difficult to achieve in National Cancer Institute-sponsored clinical trials, even while as many as 80% of those trials have faced difficulty in meeting overall recruitment targets. In an attempt to address these issues, NRG Oncology recently convened a comprehensive workshop titled "Clinical Trials Enrollment: Challenges and Opportunities." Discussants at the workshop included representatives of the three legacy groups of the NRG (ie, Gynecologic Oncology Group, National Surgical Adjuvant Breast and Bowel Program, and Radiation Therapy Oncology Group), a minority-based community clinical oncology program, a large integrated health care system, the leadership of the National Cancer Institute, and a large patient advocacy group. This article summarizes the concepts discussed at the workshop, which included: needs assessments, infrastructural support, training of investigators and research staff, specific clinical trial recruitment strategies (both system and community based), and development and mentoring of young investigators. Many new, more specific tactics, including use of diverse cancer care settings, direct-to-consumer communication, and the need for centralized information technology such as the use of software to match trials to special populations, are presented. It was concluded that new, innovative trial designs and the realities of limited funding would require the adoption of effective and efficient recruiting strategies, specialized training, and stakeholder engagement. US clinical research programs must generate and embrace new ideas and pilot test novel recruitment strategies if they are to maintain their historic role as world leaders in cancer care innovation and delivery.

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer

“…44 Experts in oncology, including members of the Minority-Based Community Clinical Oncology Program of the National Cancer Institute, and a large patient advocacy group were in attendance. 44 Ten themes emerged regarding future plans and interventions to increase minority enrollment in clinical trials; of these, 8 themes focused on the system level 44 :…”

“…61 Results of the NRG Oncology workshop identified the commitment of physicians and study investigators to the enrollment of minorities into clinical trials as critical to the future of clinical cancer research. 44 They also emphasized that physicians must be culturally sensitive and aware of the impact appropriate communication and patient trust have on minority enrollment in clinical trials. 44 …”

“…44 They also emphasized that physicians must be culturally sensitive and aware of the impact appropriate communication and patient trust have on minority enrollment in clinical trials. 44 …”

“…42,66 The NRG Oncology workshop also identified direct-to-patient communication and advertising as critical for the future of minority enrollment in clinical trials, emphasizing that this should be done with collaboration with key stakeholders such as community groups, survivor advocacy groups, and religious institutios. 44 The intersection between the impact of patient attitudes and access to trial participation illustrates the complex and multilevel nature of this issue and the need for more comprehensive interventional strategies.…”

Low clinical trial accrual of patients with myelodysplastic syndromes: Causes and potential solutions

“…3,6 Barriers to clinical trial enrollment are a topic of active investigation because these obstacles are of concern to oncologists, policy makers, advocacy groups, trial sponsors, and professional societies, as well as to the general population, who call for more rapid progress in therapy for cancer. [11][12][13][14] As clinical investigators have focused on the myelodysplastic syndromes (MDS), we are deeply concerned by the small percentage of patients with MDS in the United States who enroll in prospective clinical trials. [11][12][13][14] As clinical investigators have focused on the myelodysplastic syndromes (MDS), we are deeply concerned by the small percentage of patients with MDS in the United States who enroll in prospective clinical trials.…”