Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach

Introduction: Limited financial and human resources and infrastructure can affect the implementation of Good Clinical Practice (GCP), which can have a detrimental impact on data quality and the robustness and application of clinical trial outcomes. Monitoring frameworks are designed to ensure good data quality and help to guide adaptations of trial procedures over time. However, these frameworks tend to be based on datacentric approaches, which often neglect vital aspects of trials, such as social responsibility, capacity strengthening, and contextual influence. Therefore, this study analyses barriers and facilitators of the implementation of GCP in resource-limited settings to inform the establishment of adapted frameworks for trial management and monitoring. Methods: In this multi-method analysis of the freeBILy trial, conducted in Madagascar from 2019-2022, a random subset of trial participants (n = 500) and informed consents (n = 500) was analyzed for protocol deviations through descriptive statistics and trend analysis. Framework analysis of focus group discussions and individual semi-structures interviews provided a sociological viewpoint of the study context. Findings were subsequently triangulated, merging the viewpoints on the influences towards GCP in resource-limited settings. Results: A decreasing trend in incorrect database entries was found (z = -6.968, Mann-Kendall Test, p