Project description
New clinical trial design for tuberculosis drugs
As with many bacterial diseases, tuberculosis has been hit by drug resistance, threatening the efficacy of existing treatments. Although there are new drugs for clinical evaluation, testing the different combinations is time-consuming and requires a concerted effort. The EU-funded UNITE4TB project brings together experts in the field to design and set new standards for tuberculosis Phase II clinical trials. The team will take advantage of existing networks across continents to recruit patients in trials and introduce state-of-the-art microbiology methods and machine learning technologies. Data on biomarkers and clinical pharmacology will accompany the validation of the new drugs to ensure their subsequent success down the drug discovery pipeline.
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
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistance
- medical and health sciencesclinical medicinepneumologytuberculosis
- natural sciencescomputer and information sciencesartificial intelligencemachine learning
- natural sciencesbiological sciencesmicrobiology
- natural sciencescomputer and information sciencessoftwaresoftware applicationssimulation software
Keywords
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Funding Scheme
RIA - Research and Innovation actionCoordinator
6525 GA Nijmegen
Netherlands
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Participants (33)
WC1E 7HT London
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OX1 2JD Oxford
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23845 Borstel
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3521 AL Utrecht
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LA1 4YW Lancaster
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WC1E 6BT London
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7530 Cape Town
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
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6825 ARNHEM
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
20132 Milano
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85764 Neuherberg
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2516 AB 's-Gravenhage (Den Haag)
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2 Dublin
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
S10 2PX Sheffield
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
1040 Bruxelles / Brussel
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4050 290 Porto
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
L69 7ZX Liverpool
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13572 Marseille
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20148 Hamburg
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94607 OAKLAND CA
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10005 NEW YORK
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1202 Geneve
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20122 Milano
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KY16 9AJ St Andrews
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751 05 Uppsala
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1003 Lausanne
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23843 Bad Oldesloe
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28760 TRES CANTOS MADRID
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2340 Beerse
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80636 Munchen
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38124 Braunschweig
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80539 MUNCHEN
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
81377 Munchen
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CB2 1TN Cambridge
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