Randomised control clinical trials are considered the gold standard in health care research and our reliance on them will continue as the world seeks to find new health care interventions that solve the growing global health problems. More so in Sub Saharan Africa where the burden of disease is greater, therefore, the need to conduct trials across the developing world to answer important health questions is becoming more necessary. Multinational trials are imperative in a way of helping to address budget constraints, generalizability of results, recruiting huge sample sizes and getting results in a fairly quick timeline. Noting that clinical trials which should be conducted according to Good Clinical Practice (GCP) are the most regulated of all health care interventions and requires monitoring from the sponsor. Monitoring is essential to ensure that the rights, safety and wellbeing of clinical trials participants are protected and that the trial data are accurate, complete, and verifiable against source documents.
The PregnAnZi-2 trial is MRC Unit The Gambia at LSHTM sponsored trial conducted in two countries namely The Gambia and Burkina Faso. This is a phase II double blind randomised clinical trial aimed at preventing neonatal sepsis and death by administering Azithromycin to pregnant woman pre-delivery during active labour.
The sponsor, MRC Unit The Gambia at LSHTM, sent in two monitors to Burkina Faso from 20th to 24th Nov 2017 to conduct a site initiation visit to ensure that the site is ready to start recruiting participants for the trial.
It was a first experience for the two monitors to go beyond The Gambia to conduct monitoring visits and face new challenges especially in a Francophone country. The monitors had good rapport with the study staff. The site was found to be well equipped with an experienced study team. The trips to the study sites was the first challenge faced during the monitoring visit; the study main site is at Nanoro which is 85 KM from the capital Ouagadougou.
During the monitoring visit the two monitors were able to work with the study team to ensure that all GCP and applicable regulatory requirements were met for the site to start recruitment.