Benefit sharing and globalisation of industry sponsored clinical trials for breast cancer research

Introduction: The burden of cancer is the greatest and rising most rapidly in low-income and middle-income countries (LMICs). The survival of breast cancer is especially poor in LMICs due to late stage presentation and inadequate access to therapy. Whereas low-income countries (LICs) suffer from a generalized lack of access to cancer care, in middle-income countries (MICs) such services and facilities may exist. However, highly-priced innovative medicines are often only affordable for certain subsets of the population, and good outcomes remain biased toward those who can pay. We carried out comprehensive analysis of the geographic distribution of breast cancer clinical trials involving at least one LMICs clinical site and trials evaluating costly innovative medicines. Methodology: Data were extracted from clinicaltrials.gov registry (as of 30 Jun 2018). Advanced search filters used: (1) condition/disease: breast cancer; (2) study type: Interventional studies; (3) phases: I to IV; (4) funder type: industry. Countries were classified by income according to the World Bank (Fiscal year 2019). Results: We analysed 1,746 trials. The fraction of phase III trials involving MICs sites was 55.36% (155/280) in which Lower-MICs (L-MICs) were 27.14% (76/280) and Upper-MICs (UMICs) were 54.64% (153/280). Smaller proportions of Phase I and II trials were conducted in MICs i.e. 5.92% (26/439) and 16.23% (161/992). Phase IV trials that involve MICs were 31.43% (11/35). No trials were conducted in LICs. L-MICs countries with the highest number of trials were India (n = 63) and Ukraine (n = 56) followed by Philippines (n = 23), Egypt (n = 17), and Pakistan (n = 10). For U MICs, Russian Federation (n = 141), Brazil (n = 113), China (n = 112), followed by Mexico (n = 88) and Turkey (n = 66). Conclusion: Our analysis of the case of industry sponsored clinical trials with new, innovative medicines for breast cancer confirms previous observations with rarer blood cancers, that such trials are increasingly globalized, i.e., delocalized to countries that do not have the means to ensure (universal) access to high-cost medicines. Although substantial numbers of anti-cancer medicines are nowadays included in national lists of LMICs, their affordability and accessibility at country-level are often far from ensured. The relevance of benefit sharing in international research is still poorly understood. A legal framework formulating benefitsharing requirements in international research is necessary