In May 2018 an outbreak of Ebola in the northwest of the Democratic Republic of the Congo brought to the spotlight once again the necessity for rapid outbreak response. This is another example of why ITM is keenly involved in partnerships across the world that look to better our global efforts to save lives when epidemics hit. Such a coalition is the African CoaLition for Epidemic Research, Response and Training (ALERRT) that was officially launched in March 2018 to span five years.
The 21 partner organisations, including ITM, refer to themselves as “a multi-disciplinary consortium building a patient-centred clinical research network to respond to epidemics across sub-Saharan Africa”. Out of its seven working groups ITM is co-lead on the ICT and Data Management (DM) working group and is participating in the clinical research platform – two areas where our experience and close historical connections with African partners can have high impact.
This article was previously published in the 7th issue of the biannual P³ magazine.
Prof Johan van Griensven is representing ITM on the ALERRT general assembly and is leading the ITM team involved in the clinical research platform: “From our experience with the Ebola epidemics, we know that being a part of the ALERRT network among others is essential for ITM. Over the next five years, we will focus on the areas that proved difficult at the time. For example in the setting up and conducting of clinical trials where bottlenecks in regulatory and ethics committees proved cumbersome and made us lose precious time.”
Van Griensven explains that in the past activities in epidemics focused on humanitarian response, disease control and the essential nature of the fact that lives needed saving.
“Unfortunately, historically there has been distrust between humanitarian organisations and researchers. Research was often seen as getting in the way of the key goal of saving lives but recent epidemics have shown we need to be able to conduct research during epidemics to come up with vaccines, new diagnostic tools and treatments and save even more lives. A consortium such as ALERRT is looking to change this dynamic so that we can work together to ensure rapid response on all fronts.”
Another front that can greatly enhance reactions during disease outbreaks is information systems and data management. This is why ITM is co-lead in the ICT and DM Work Package.
“Having clean and accurate data sets is essential in any research. For clinical trials you need to ensure also that data handling and management is compliant with Good Clinical Practice and regulations,” says Harry van Loen from ITM’s Clinical Trials Unit. “In our work package we are concentrating on the preparation of DM documentation, this can be for example Standard Operating Procedures or Data Management Plans, and capacity building of African partners. Our biggest challenge is in the areas of existing knowledge and experience and in creating awareness of the whole DM workflow, its deliverables, quality assurance and timelines. That’s why we are looking to build this within our consortium partners. This will also ensure that the technology systems needed to support clinical trials in resource-poor settings can be put in motion quickly in times of outbreak.”
Working on these two fronts, ITM is looking forward to significantly contributing to the essential objectives of the consortium along with 20 other partner organisations from 13 countries (nine African and four European). The consortium has been awarded a €10 million grant from the European and Developing Countries Clinical Trial Partnership for a five year period.
Find out more about the ALERRT consortium at www.alerrt.global
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