Barriers and facilitators of clinical trial enrollment in a network of community‐based pediatric oncology clinics

Abstract

Introduction Major advances in the field of pediatric oncology have resulted from rigorous, prospective clinical oncology research trials. Optimizing access for all children and adolescents to clinical research trials is an important goal. Barriers to clinical trial enrollment are numerous, involving the health care system, research infrastructure, access to care, providers, and participants. The perspectives of pediatric oncologists may provide insight into the barriers of clinical trial enrollment for this unique population. Methods and materials We conducted qualitative structured interviews over two months of pediatric oncologists in a community‐based clinical network as part of a quality improvement project aimed at increasing enrollment rates at St. Jude Affiliate Clinics. We assessed barriers and facilitators to clinical trial opportunities for racial and ethnic minority pediatric participants. In the same fiscal year of the interviews, we tracked clinical trial enrollment by race and ethnicity of the participant over 12 months. Results The major barriers to clinical trial enrollment for pediatric cancer minority participants included language discordance, travel difficulties, and complex trial designs. In contrast, the major facilitators included building trust with participants and their parents, and education on the merits of clinical research studies. We did not observe any disparities in clinical trial enrollment among the racial and ethnic minority participants of the clinical trials conducted across our network of pediatric oncology clinics. Conclusions Identifying barriers and facilitators may improve clinical trial enrollment for underrepresented participant groups.

Diverse populations and enrollment in pediatric cancer clinical trials: Challenges and opportunities

“…Recently, Russo et al published in this journal that major barriers to CTs enrollment for minority patients at St. Jude Affiliate Clinics included language discordance, travel difficulties, and complex CT designs 16 . Major facilitators included building trust with parents and education about the merits of CTs.…”

“…The role of mistrust in pediatric CTs has not been well studied. Russo et al provide new insights from providers regarding minority enrollment to cancer CTs, 16 which adds to existing literature that describes the perspectives of potential participants. Thus, recognizing and managing mistrust may play a role in increasing minority CT enrollment.…”

“…Strategies at the clinical level should aim at reducing the rigidity of inclusion/exclusion criteria to ensure that the CT population is a better reflection of patients who are most likely to receive those therapies. As described by Russo et al, regional partnerships between large academic cancer centers and satellite sites in underserved communities can be established to increase enrollment 16 . Moreover, the role of telehealth in improving CTs enrollment in pediatrics is yet to be investigated.…”

Parental decision making regarding consent to randomization on Children's Oncology Group AALL0932

“…Given the study eligibility, concerns from parents who declined the upfront enrollment on AALL0932 were not captured. We excluded the two Spanish‐speaking families and, thus, were not able to get perspectives from an important population within pediatric oncology that has been shown to have lower clinical trial enrollment rates 44–46 …”

Role of implicit bias in pediatric cancer clinical trials and enrollment recommendations among pediatric oncology providers

“…Similar to national data, average enrollment approximates 50% to 60%; however, enrollment from some affiliate sites is as low as 20%. In an effort to understand this variation, we previously investigated physician‐perceived barriers to clinical trial enrollment across the SJCRH affiliate network 7 . We identified 3 major barriers: language discordance, transportation issues, and complex trial design.…”