Descripción del proyecto
Lucha contra las enfermedades tropicales desatendidas mediante ensayos clínicos adaptativos
Las enfermedades tropicales desatendidas (ETD) son un grupo de infecciones parasitarias y bacterianas que afectan a más de mil millones de personas en todo el mundo, la mayoría en zonas de renta baja. El África subsahariana se ve desproporcionadamente afectada, con cerca del 40 % de la carga mundial de ETD. El equipo del proyecto eWHORM, financiado con fondos europeos, pretende mejorar la infraestructura de investigación clínica y establecer una plataforma de ensayos clínicos adaptativos. En concreto, desarrollará un fármaco que actúe con seguridad en múltiples especies de helmintos. Evaluará la eficacia del fármaco pannematológico oxfendazol, que es barato y de libre acceso, en un ensayo clínico adaptativo contra la oncocercosis, la loasis, la mansonelosis y la tricuriasis. La asociación interdisciplinar del proyecto entre ocho países garantizará el desarrollo de capacidades sostenibles en los países del África subsahariana y un método centrado en el paciente para cartografiar con precisión los programas de erradicación.
Objetivo
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.
Palabras clave
Programa(s)
- HORIZON.2.1 - Health Main Programme
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaRégimen de financiación
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinador
53127 Bonn
Alemania