Background To fight neglected tropical diseases (NTD), clinical trials implemented in endemic settings are crucial. This requires high standards of Good Clinical Practice (GCP) to ensure participant safety and reliable data. Yet, the local implementation can be challenging due to limited resources, remote study sites, or inexperienced staff. This study aims at assessing barriers and facilitators to implement GCP in limited resources contexts through the example of the clinical trial freeBILy.

Methods A mixed-methods design was used: quantitative data to measure frequencies and extent of GCP nonconformities were extracted from the trial database, while qualitative data were collected among trial staff (n=30) through in-depth interviews and focus group discussions. A closed questionnaire captured background information of the staff. Statistical analysis with R® includes classification of nonconformities by error type and severity, as well as regression analysis of sociocultural factors associated with nonconformities. Qualitative data are being analyzed following a thematic approach. Triangulation of the data will be performed.

Results From a random sample of 500 study IDs of enrolled women, a total of 331,349 data entries have been retrieved from the database and organized to proceed with the regression analysis. The informed consents of the same 500 women were manually reviewed. A total of 30 nurses and midwives with a median age of 30 years (IQR: 29, 34) were qualitatively interviewed. The majority were female (77%) with a university degree (100%), fluent in French (86%), and had received GCP training in the last 2 years (97%).

Conclusion Our preliminary data show that the involved staff were well educated and regularly attended GCP trainings, challenging the stereotype of inexperienced staff in SSA. Further analysis will assess association of specific factors with frequencies and type of nonconformities in order to inform implementation strategies of future trials.