What is a clinical study (or clinical trial)? It is the most rigorous scientific method for providing scientific evidence. It can prove that a treatment works better or worse than another. The strength of its results is based on accurate data collection.
ALIMA (The Alliance for International Medical Action) has launched a clinical study in Niger, in a region bordering Nigeria, known for its difficult humanitarian and security situation. “It is true that such trials require a lot of quality requirements and that remains a challenge in such a context,” concedes Maguy Daures, epidemiologist and scientific project manager for OptiMA in Niger. Maguy is based in Bordeaux at Inserm, ALIMA’s research partner since 2016.
The hope of saving more lives
For ALIMA, taking up this kind of challenge is essential, because participating in research is also participating in medical progress. And in these particularly fragile humanitarian contexts, it is a source of hope, the hope of saving more lives. The hope brought by the OptiMA (Optimizing the Management of Acute Malnutrition) research project is considerable: to detect and treat children suffering from acute malnutrition more efficiently, in order to reduce mortality linked to this scourge.
The teams rolled up their sleeves and faced each obstacle with determination. First, they had to be patient. As with all clinical studies of this magnitude, there is a long preparatory phase, about a year, during which a team of researchers and doctors must “formulate the research question, write a detailed protocol, have it validated by several ethical committees, etc.,” says the epidemiologist.
Next, the question of communication with communities was crucial. Indeed, in order to get as many people as possible to join the project, it was very important to discuss with the village leaders. Fair and accurate communication, with clear messages that are accessible to the community, helps to avoid rumors that are unfavorable to the study. Therefore, more than 200 village chiefs were educated in the local language.
An unprecedented demand for quality
Training Nigerien medical personnel was also an important issue. Since the country lacks personnel with specialized technical skills for this study, a complete team had to be recruited and trained. “We’re not used to clinical trials in Niger because it’s expensive, so no one here has experience,” explains Dr. Jérémie Hien, OptiMA project manager in Niger. “We had to train the local teams to get used to the very meticulous and rigorous collection tools and to become competent in the research. It is ALIMA’s trademark to work with national agents, but it was essential to collect high-quality data, so the burden was heavy.”
Inventory management was another issue, this time logistical. Therapeutic food paste, also known as “ready-to-use therapeutic food” or RUTF, was in short supply in the country even before the study began. Unfortunately, Niger is often faced with stock-outs and this was the case during this trial. The launch of the project had to be delayed. The availability of this product throughout the study was a constant concern because a stockout would have distorted the collection and undermined the entire work.
Adapting, innovating and moving forward
In a field without internet, with a lot of sand, dust, and motorcycle travel between villages, it was necessary to innovate and adapt the collection tools. Resistant tablets and easy-to-use software were developed in partnership with researchers at the PAC-CI research center in Abidjan. The follow-up of the 2,303 children included in the study was therefore particularly complicated. More than 100 community relays were recruited and trained to identify dropouts or absentees in order to motivate them to return for follow-up.
From a security point of view, we also had to adapt. The area where the trial took place was not accessible to the experts from Bordeaux. This was a disappointment for the teams involved: “I was frustrated to have been involved in setting up such a trial without being able to come and implement and evaluate it,” says Maguy. “Everything was done remotely. It’s the first time we’ve had a clinical trial of this magnitude without being able to go, and if the context had deteriorated we would have had to stop everything.” Fortunately, the situation, although tense at times, especially during the election period, did not prevent the study from going ahead.
Despite everything, the ALIMA teams did not give up, because it is crucial that no one is left behind. In any context , the teams were able to adapt, innovate and move forward. Data collection was completed at the end of June 2022. The data is now being analyzed by INSERM scientists in Bordeaux, and results are planned for publication in 2023.
Cover picture © Alexandre Bonneau / ALIMA