Challenges and opportunities in the design and implementation of breast cancer clinical trials in the developing countries

Author(s): Sudeep Gupta, Shona Nag, Shaheenah Dawood

Breast cancer is an increasingly recognized public health concern in developing countries. The clinical spectrum is heterogeneous but largely characterized at presentation by a more advanced stage, the presence of various adverse factors and low rate of survival. The quantum of ongoing clinical trials in breast cancer is low and inadequate to address the needs of these populations. There are several design challenges in setting up breast cancer trials in the developing world, the most notable being the aquisition of informed consent, inducement and/or coercion of participants, adequacy of control arms in randomized trials, tropical infections and ethnic variations in drug metabolism. The main implementation challenges include scarcity of infrastructure and skilled human resources, variable delivery of standard breast cancer care, inadequate breast cancer pathology standards and deficient regulatory framework in many regions. There are several opportunities for conducting clinical trials that include a large number of less-heavily treated, advanced-stage patients and lower cost. There is a trend towards an increasing number of clinical trials in these regions that is likely to be sustained in the future.