Project description
Tackling neglected tropical diseases through adaptive clinical trials
Neglected tropical diseases (NTDs) are a group of parasitic and bacterial infections affecting over one billion people worldwide, mostly in low-income areas. Sub-Saharan Africa (SSA) is disproportionately affected, with around 40 % of the global NTD burden. The EU-funded eWHORM project aims to improve clinical research infrastructure and establish an adaptive clinical trial platform. Specifically, it will develop a drug that acts safely on multiple helminth species. It will assess the efficacy of the cheap and freely-accessible pan-nematode drug oxfendazole in an adaptive clinical trial against onchocerciasis, loiasis, mansonellosis, and trichuriasis. The project’s interdisciplinary partnership between eight countries will ensure sustainable capacity building within SSA countries and a patient-centric approach to precision mapping for elimination programmes.
Objective
We will establish for the first time in NTDs an adaptive clinical trial platform and improve clinical research infrastructure in four SSA countries. A drug acting safely on multiple helminths species would be a major leap to tackle NTDs and enable the WHO RoadMap (eWHORM). The cheap and freely-accessible pan-nematode drug oxfendazole (OXF) has such potential. Given the limited portfolio of anthelmintic drug candidates, eWHORM will assess its efficacy in an adaptive clinical trial for simultaneous evaluation against onchocerciasis, loiasis, mansonellosis and trichuriasis. Thus not only the largest group of NTDs, but also diseases that are not (yet) listed will be adressed. This design significantly reduces patient numbers, development time-frames and enables treatment of co-infections. Combined with our highly sensitive molecular tests, we provide a patient-centric approach providing tools for targeted treatment (test and treat) and precision mapping for elimination programs. Strengthening of early career scientists in SSA in all aspects of clinical trial conduct and research including data management, simulation and statistical analysis, will be fostered by introducing a master and PhD program, a mentorship program as well as several webinars. An open-source virtual training and assessment tool for diagnosis of NTDs will complement the knowledge transfer to remote areas in SSA. The consortium encompasses an interdisciplinary partnership from eight different countries (Germany, the Netherlands, Austria, Switzerland, Cameroon, Gabon, Tanzania, and DRC). Each group brings unique knowhow and recognized complementary experience to the project to ensure sustainable capacity building within SSA countries. Through joint development of – and training in – modern, regulatory clinical trial conduct, adaptive clinical trial design and state-of-the-art diagnostics, we will strengthen SSA researchers and clinicians to respond to persisting and future health challenges.
Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinator
53127 Bonn
Germany