Defining clinical trial quality from the perspective of resource-limited settings: a qualitative study based on interviews with investigators, sponsors, and monitors conducting clinical trials in sub-Saharan Africa

In recent decades, the quality management of clinical trials has been criticised for being inefficient and ineffective. This has led to a waste of clinical trial investment and has made it particularly difficult to conduct clinical trials in settings with limited resources. The lack of a universally accepted comprehensive definition of clinical trial quality was suggested as one of the possible causes of inadequate quality management. However, resource-limited countries were not considered in the attempt to create such a definition. In our study, we developed a quality concept based on qualitative interviews from the perspective of investigators, sponsors, and monitors with experience in conducting clinical trials in sub-Saharan Africa. The analysis of these stakeholders' definitions of clinical trial quality has produced a Clinical Trial Quality Concept that includes quality promoting factors (i.e., Context adaptation; Infrastructure; Partnership; Operational excellence; Quality system) in addition to conventional scientific and ethical factors. The results thus support the need for a multidimensional quality concept to reflect clinical trial quality more comprehensively. We recommend the term "Comprehensive Quality Management (CQM)" for this concept. CQM has the potential to serve as a basis for the current revision of quality management principles in international clinical trial guidelines. Furthermore, the sub-Saharan African perspective has highlighted additional considerations compared to the existing comprehensive INQUIRE clinical trial quality framework. Therefore, we propose including the following three points relevant to resource-limited settings in the framework: 1) Communicating potential infrastructural disadvantages to funders, sponsors, and auditors. 2) Preventing potential exploitation of research populations and workforce in low- and middle-income countries by following existing ethical frameworks. 3) Including "Context adaptation" as an additional framework category (i.e., promoting factor).