Anticipating and strategizing to address potential bottlenecks during clinical research projects in sub-Saharan Africa: a case for adapting approaches and tools used in the entrepreneurial and development sectors.

Many research funders have invested billions of US dollars in building research capacity in sub-Saharan Africa (SSA). Despite these colossal investments, many well-intentioned and designed clinical research projects have either failed to kick off or ended abruptly. Although obstacles to clinical research in SSA are well known, there is limited information on frameworks and tools that can be used to anticipate and avert these systemic bottlenecks, particularly those related to socio-politics. In this paper, we leveraged lessons from entrepreneurs and development experts in harsh and uncertain business environments to develop a framework for anticipating and addressing potential bottlenecks to clinical research in SSA. More so, to illustrate and build a case for this framework, we shared our experience in supporting clinicians and regulators to adopt a point-of-use care tool, the "chemoPAD," to screen for the quality of anticancer medications rapidly and systematically in Cameroon despite resistance from some stakeholders. The critical steps in this framework involve identifying stakeholders, categorizing them based on their potential reactions to the study (adversary, supporters, and indifferents), and developing critical strategies to engage or deal with each stakeholder's reactions, starting with adversaries. This approach may be useful in complex research projects, especially clinical trials, which often involve many stakeholders with different interests and perceptions.