Randomized clinical trials on breast cancer in Nigeria and other developing countries: Challenges and constraints

Abstract

Worldwide, breast cancer is the commonest cancer among women, and its incidence is rising exponentially particularly in developing countries. Compared with Caucasian women, women in developing countries experience a disproportionate burden of aggressive Triple Negative Breast Cancer for reasons that remain unknown and understudied. There is a high incidence of late stage presentation, low level of public awareness of the disease, suboptimal health infrastructure, lack of universal access to affordable interventions and poor prognosis. A randomized controlled trial or randomized control trial (RCT) is a type of scientific (often medical) experiment, where the people being studied are allocated at random (by chance alone) to receive one of several clinical interventions. These kinds of studies are vital in the development of new treatments and interventions for serious diseases like breast cancer, malaria, TB and HIV which are ravaging developing and often resource-poor countries. The need for more randomized clinical trials on breast cancer in developing countries cannot be overemphasized as it creates a unique opportunity to generate data and possibly develop affordable interventions that are responsive to the peculiar health challenges rather than relying on data from the West which may not be representative. Several limiting factors exist that can potentially affect the effectiveness of these trials. These challenges include; ethical challenges, bureaucracy in government, late stage of presentation, high prevalence of triple negative breast cancers, follow up challenges, cost-related challenges, sub optimal health infrastructure, poor implementation of clinical governance, suboptimal number of trained clinical trial personnel, poor laboratory capacity, informed consent-related issues, poor data management, suboptimal number of trained statisticians, challenge of poor awareness and stigma associated with breast cancer, logistics and accessibility issues concerning management of health products, education and communication-related challenges and cultural and religious issues. Objective approaches to these challenges are vital to the successful implementation of fit-for-purpose randomized clinical trial particularly on breast cancer in Nigeria and other developing countries.