Background Over the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.
Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.
Methods We conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).
Results A total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.
Conclusion The rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.