Abstract
BackgroundThe trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.MethodsWe used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews.ResultsProtocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures.ConclusionsOur data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.
Highlights
The trial protocol is the most important document for clinical trials and describes the design and methodology of a study, and all practical aspects
We developed the survey in a team that included clinical researchers, a statistician and a social scientist and discussed it with and received input from the European & Developing Countries Clinical Trials Partnership (EDCTP), a funder of investigator-initiated trials and active in sub-Saharan Africa (SSA) since 2003
To follow up on this topic, we added questions about protocol suitability to the remaining eight interviews in Ghana
Summary
The trial protocol is the most important document for clinical trials and describes the design and methodology of a study, and all practical aspects. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. From a public health perspective, clinical trials in sub-Saharan Africa (SSA), where high burdens of disease exist, are of particular importance. Trials conducted in this region face particular setting-specific challenges like deficits in infrastructure and skilled workforce, in addition to the. The most important document in a clinical trial is the trial protocol, the key document for planning, conducting, externally reviewing, overseeing and interpreting a study [2]. The study design described in the protocol significantly affects the costs of conducting
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