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

Abstract

Background Increasing clinical trial cost and complexity, as well as a high waste of clinical trial investment over the past decades, have changed the way clinical trial quality is managed. Recent evidence has highlighted that the lack of a clear clinical trial quality definition may have contributed to previous inefficiencies. This study aims to support the understanding of what clinical trial quality entails from the perspective of resource-limited settings. Methodology/Principal findings We conducted 46 semi-structured interviews involving investigators, sponsors, and monitors with experience in conducting clinical trials in 27 countries in sub-Saharan Africa. The questionnaire addressed the overall meaning of clinical trial quality and a conclusive clinical trial quality definition, as well as specific aspects of resource-limited settings across the clinical trial process. We held the interviews either in person, via Skype or by phone. They were recorded and transcribed verbatim, and we performed the analysis using The Framework Method. The analysis of clinical trial quality definitions resulted in 11 elements, which were summarised into a clinical trial quality concept consisting of two components: 1) clinical trial quality building factors (Scientific factors and Moral factors) and 2) promoting factors (Context adaptation; Infrastructure; Partnership; Operational excellence; Quality system). 12 resource-limited settings specific themes were identified. These themes were all categorised under the promoting factors "Context adaptation", "Infrastructure", and "Partnership". Conclusions/Significance We found that in order to enable comprehensive clinical trial quality management, clinical trial quality should be defined by a multidimensional concept that includes not only scientific and ethical, but also quality-promoting factors. Such a concept is of general relevance and not limited to clinical trials in resource-limited settings, where it naturally carries particular weight. In addition, from the perspective of sub-Saharan Africa, we identified specific categories that appear to be critical for the conduct of clinical trials in resource-limited settings, and we propose respective changes to a particular existing clinical trial quality framework (i.e., INQUIRE).

Online interviews for qualitative health research in Africa: a scoping review

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“…Only four studies piloted their interviews (only one of four pilot studies was conducted with participants based in Africa). 21 , 26 – 28 Five studies were conducted in multiple countries, including South Africa, Kenya, Malawi, Sierra Leone, Somalia, Uganda, Sudan and Zimbabwe. The details of the studies (including study purpose) can be found in Table 2 .…”

“… 27 Similar recruitment approaches (contacting experts and posting on social media) were adopted by two other studies. 24 , 26 In other studies, snowball sampling was used by first contacting and recruiting people within researchers’ professional and social networks via E-mail and subsequently ‘snowballing’ via them to reach more participants. 24 , 26 , 28 …”

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

“…All involved researchers have extensive experience in the conduct of clinical studies. In addition, all of them had received specific trainings in qualitative research and made previous contributions to mixed method studies about the quality and efficiency of clinical studies, and immunisation mainly in resource-constrained settings 20–23. The researchers did not have working experience with the sites where the study was conducted.…”

Toward a New Paradigm of North–South and South–South Partnerships for Pandemic Preparedness: Lessons Learned from COVID-19 and Other Outbreaks

“…2 However, clinical trial funding and research capacity has historically flowed from the Global North to the Global South, thus maintaining power imbalances between high- and low-income countries 3 and eroding local capacity to lead research and evidence mobilization. 4 , 5 With the increasing recognition that resilience is an essential property of a health system when shocked or stressed, 6 , 7 building capacity for countries in the Global South to respond to their own needs has never been more important.…”