Loading grant details…
ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS
| Funder | European Commission |
|---|---|
| Recipient Organization | Stichting Radboud Universitair Medisch Centrum |
| Country | Netherlands |
| Start Date | Jun 01, 2021 |
| End Date | May 31, 2028 |
| Duration | 2,556 days |
| Number of Grantees | 32 |
| Roles | Participant; Third Party; Coordinator |
| Data Source | European Commission |
| Grant ID | 101007873 |
Grant Description
Current anti-tuberculosis (TB) drug regimens face serious limitations at times of increasing antimicrobial drug resistance. Fortunately, for the first time for centuries, several novel anti-TB compounds are available for clinical evaluation.
As the traditional approach to testing these in multiple combination regimens is too slow and inefficient new approaches of clinical phase 2 study designs are required if we are to meet the targets of the WHO EndTB strategy to save the lives of millions into the near future.
Our consortium brings together a unique group of European and international leaders in TB research and leading industry partners.
Together we will provide the necessary comprehensive range of expertise to meet the demands of the UNITE4TB scientific research agenda.
Specifically, we will develop a new global standard for phase 2 TB clinical trial designs, utilising simulation tools to identify optimal doses in phase 2A trials and apply a multi-arm multi-stage adaptive randomised controlled 2B/C trial design capable of rapid and simultaneous evaluation of the best candidate regimens.
Our innovative phase 2 trials will be performed to the highest regulatory standards, incorporating state-of-the-art microbiology, biomarker investigation and clinical pharmacology.
We will take advantage of existing global TB clinical trial networks with the capacity to enrol patients at an unprecedented pace and number across four continents.
Artificial intelligence/machine learning technologies will be applied to validate state-of-the art molecular and imaging tools as treatment decision biomarkers with the aim of establishing new, real-time outcome measures.
Our consortium will evaluate 3-5 new chemical entities (NCEs) at phase 2A and up to 17 novel combination regimens in phase 2B/C.
Our objective is to identify those that have the greatest chance of success in subsequent definitive phase 3 clinical trials and of becoming the global gold-standard TB regimens of the future.
All Grantees
Ludwig-Maximilians-Universitaet Muenchen; The Chancellor Masters and Scholars of the University of Cambridge; Global Alliance for Tb Drug Development Non Profit Organisation; Stichting Lygature; Helmholtz Zentrum Muenchen Deutsches Forschungszentrum Fuer Gesundheit Und Umwelt Gmbh; Task Foundation Npc; Koninklijke Nederlandse Centrale Vereniging Tot Bestrijding Der Tuberculose (Kncv); Klinikum Der Ludwig-Maximilians-Universitat Munchen; Uppsala Universitet; The University Court of the University of St Andrews; Stichting Radboud Universitair Medisch Centrum; Tuberculosis Network European Trialsgroup Ev; University of Hamburg; Instituto de Saude Publica Da Universidade Do Porto; London School of Hygiene & Tropical Medicine; Lungs Europe; Foundation for Innovative New Diagnostics; Deutsches Zentrum Fur Infektionsforschung (Dzif) Ev; The Regents of the University of California; The University of Liverpool; Universita Degli Studi Di Milano; Glaxosmithkline Investigacion Y Desarrollo Sl; The Chancellor, Masters and Scholars of the University of Oxford; University College London; European Respiratory Society; Institut de Recherche Pour Le Developpement; Critical Path Institute, Limited; European Lung Foundation; Otsuka Novel Products Gmbh; Forschungszentrum Borstel Leibniz Lungenzentrum; Janssen Pharmaceutica Nv; Universita Vita-Salute San Raffaele
Interested in applying for this grant?
Complete our application form to express your interest and we'll guide you through the process.
Apply for This GrantQuick Summary
Related Grants
