Disparities in phase 1 cancer clinical trial enrollment

Abstract

Background Phase 1 trials are increasingly important in the molecularly driven era of oncology, but few studies have examined phase 1 participation disparities. The authors of this study investigated factors associated with phase 1 versus phase 2/3 trial enrollment. Methods They authors conducted a cross‐sectional study using serial samples of patients age ≥18 years enrolling on cancer trials from October 2011 to November 2014 at an academic cancer center. They used univariable and multivariable logistic regression models to analyze sociodemographic and clinical associations with phase 1 versus phase 2/3 trial enrollment. Results Among 3103 patients enrolled in cancer trials, 2657 unique patients participated in phase 1/2/3 trials. For patients enrolled in phase 1 (n = 1401) versus phase 2/3 (n = 1256) trials, we found no significant differences by age, insurance status, marital status, and income. Overall, 1216 (93%) White, 72 (6%) Asian, and 21 (2%) Black patients enrolled on phase 1 trials, whereas 1068 (93%) White, 40 (3%) Asian, and 43 (4%) Black patients enrolled on phase 2/3 trials. Adjusting for age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year, compared with White patients, Black patients had lower phase 1 enrollment (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.25‐0.82), as did Hispanic/Latino (OR, 0.25; 95% CI, 0.08‐0.79) and male patients (OR, 0.77; 95% CI, 0.62‐0.94). Asian patients had higher phase 1 enrollment (OR, 1.38; 95% CI, 0.88‐2.16). Conclusions Disparities in phase 1 versus phase 2/3 cancer clinical trial enrollment underscore the urgent need for interventions addressing inequities in early‐phase trial participation. Lay Summary Phase 1 trials are of increasing importance in oncology. The authors of the study analyzed all patients enrolling on cancer clinical trials at a large academic cancer center from October 2011 to November 2014. Among the 2657 trial participants, when age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year were taken into account, Black, Hispanic/Latino, and male patients were less likely to enroll on phase 1 trials versus phase 2/3 trials. These findings suggest a need for targeted interventions to improve access to and education about phase 1 trials for Black and Hispanic/Latino patients.

Participation of Patients From Racial and Ethnic Minority Groups in Phase 1 Early Cancer Drug Development Trials in the US, 2000-2018

“… 4 , 9 Similar disparities in phase 1 cancer clinical trial enrollment have been noted in studies conducted at single institutions. 10 …”

“…4,9 Similar disparities in phase 1 cancer clinical trial enrollment have been noted in studies conducted at single institutions. 10 When examining racial and ethnic disparities in clinical research, it is essential to acknowledge the harms that individuals of racial and ethnic minority groups have experienced at the hands of the US health care system, especially in the research setting. 11 These historical harms have led to mistrust of academic and research institutions and investigators, which is further exacerbated by current socioeconomic and health care system inequities.…”

A Lack of Diversity, Equity, and Inclusion in Clinical Research Has Direct Impact on Patient Care

“…These results withstood adjustments for important confounders such as age, sex, insurance status, marital status, income, cancer type, and travel distance. 20 Informed consent forms are often only available in the dominant language of a country and ethnic minorities with limited language proficiency will not be able to participate in trials. A focus on patient friendly recruitment material for trials may facilitate enrollment of participants with broader ethnic, educational, and socioeconomic backgrounds.…”

Developing a Virtual Equity Hub: Adapting the Tumor Board Model for Equity in Cancer Care

“… 6 Populations served in health safety net settings with Medicaid insurance have lower rates of participation in cancer clinical trials, particularly among Black and Latino patients. 7 , 8 The Covid-19 pandemic has compounded the risk of delays in cancer diagnosis and treatment for underserved populations given higher rates of Covid-19 infection and job loss, increasing the disproportionate burden of care on clinicians and systems caring for populations in safety-net settings. 9 , 10 At the same time, safety net hospitals are trusted care settings with unique expertise in the population served including shared culture, language, illness understanding, and a history of adversity and collective action.…”