Objective
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.
Fields of science
Programme(s)
Topic(s)
Call for proposal
H2020-JTI-IMI2-2020-20-two-stage
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Funding Scheme
IMI2-RIA - Research and Innovation actionCoordinator
6525 GA Nijmegen
Netherlands
Participants (29)
WC1E 7HT London
OX1 2JD Oxford
23845 Borstel
3521 AL Utrecht
LA1 4YW Lancaster
WC1E 6BT London
7530 Cape Town
20132 Milano
85764 Neuherberg
2516 AB 'S Gravenhage
2 Dublin
S10 2PX Sheffield
4050 290 Porto
L69 7ZX Liverpool
13572 Marseille
20148 Hamburg
94607 Oakland Ca
10005 New York
1202 Geneve
20122 Milano
KY16 9AJ St Andrews
751 05 Uppsala
1003 Lausanne
23843 Bad Oldesloe
28760 Tres Cantos Madrid
2340 Beerse
80636 Munchen
38124 Braunschweig
80539 Muenchen