Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

Abstract

PurposeAs cancer burden has risen worldwide, physicians, patients, and their advocates have become aware that the clinical cancer trial research paradigm is not ubiquitous. Furthermore, the number and characteristics of trials that are registered in low- and middle-income countries (LMICs) compared with that in high-income countries (HICs) are unknown.MethodsWe collected retrospective data on trials for breast, lung, and cervical cancer registered in ClinicalTrials.gov or with the WHO International Clinical Trial Registry Platform between 2010 and 2017. The data were then classified as trials within LMICs or HICs using definitions from the World Bank.ResultsIncluded in these analyses were 6,710 trials, of which 3,164 (47%) were breast cancer trials, 3,283 (49%) were lung cancer trials, and 263 (4%) were cervical cancer trials. There were 1,951 (29%) trials from LMICs and 4,759 (71%) trials from HICs (P < .001). Although the proportion of phase III trials in HICs versus LMICs was similar (18% v 17%; P = .66), the number of phase I trials in LMICs was significantly lower than that of HICs (20% v 2%; P < .001). For several LMICs with the highest mortality-to-incidence ratios for breast, lung, or cervical cancer, there were no cancer trials registered in the registration data bases searched for this work.ConclusionThere are differences in access to cancer clinical trials in LMICs compared with HICs. Several factors, such as excessive cost and a lack of infrastructure and expertise, may explain these differences.

A multilevel assessment of the social determinants associated with the late stage diagnosis of breast cancer

“…The specialized services that present adequate infrastructure and trained health professionals for cancer assistance are usually located in the larger Brazilian urban centers. These facilities are commonly overburdened with the high demands for healthcare 23 .…”

Spatial distribution of advanced stage diagnosis and mortality of breast cancer: Socioeconomic and health service offer inequalities in Brazil

“…However, the high demand for healthcare causes the incapacity of the public system to attend the collective health necessities, which leads the population to search for private health services [ 34 ]. The unequal territorial distribution of resources and health technology results in the concentration of cancer assistance services in large urban centers of Brazil [ 35 ].…”

MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2– advanced breast cancer: the multinational randomized phase III study

“…A strength of the current study is that it is the first phase III study designed to assess prospectively the efficacy and safety profile of abemaciclib in patient populations from China, Brazil, India, and South Africa, where clinical research resources are limited. 14 The innovative study design allowed efficient assessment of two treatment settings in a single study, while ensuring sufficient power for the primary endpoint. A possible limitation of this study is that cohort B was designed with a sample size to show consistency (defined as 80% probability to retain at least 50% of the effective size in PFS) with MONARCH 2 and had no alpha reserved or gated for formal statistical testing.…”