About
Workstreams and Work Packages
Work Package 1
Project management, coordination, and sustainability
WP1 provides overall leadership and supports project governance and consortium decision-making. The WP is responsible for the setup and management of external scientific and regulatory advisory boards. It also ensures that the consortium’s contractual duties are met.
Leading partners
Work Package 2
Clinical trial design
The overall aim of WP2 is to develop innovative adaptive phase 2 trial designs. This includes delivering both a phase 2A and phase 2B/C clinical trial design framework and statistical analysis of the phase 2 studies.
Leading partners
Work Package 3
Pharmacology & pharmacogenomics
The overall aim of WP3 is to enable evidence-based dose- and regimen selections and evaluate the need/potential for treatment individualization using patient covariates. As part of the phase 2 studies, it will also be responsible for the bioanalysis generating high-quality pharmacokinetic data.
Leading partners
Work Package 4
Phase 2A clinical trials
The overall aim of WP4 is to conduct good clinical practice (GCP)-compliant and regulatory-standard phase 2A clinical trials and study microbiological and other biomarkers for the clinical development of phase 2-ready new chemical entities (NCEs)
Leading partners
Work Package 5
Phase 2B/C clinical trials
The overall aim of WP5 is to perform good clinical practice (GCP)-compliant and regulatory-standard phase 2B/C trials, conducted within a global network of sites and using innovative, maximally efficient trial designs to provide the evidence to progress novel regimens to phase 3 trials.
Leading partners
Work Package 6
Microbiology, including bacterial biobank
The overall aim of WP6 is the implementation of a laboratory quality assurance & monitoring program and the integration of state-of-the-art microbiological technologies to ensure that the highest quality microbiological data is generated in the phase 2 studies.
Leading partners
Work Package 7
Biomarkers
The overall aim of WP7 is to identify biomarkers that predict relapse as the main clinical endpoint, especially of phase 3 trials, to allow a shortening of trials and potentially a reduction in sample size, which will lead to an acceleration of drug development in general.
Leading partners
Work Package 8
Artificial intelligence & machine learning
The overall aim of WP8 is to develop and apply artificial intelligence & machine learning (AI/ML) methods for the prediction of relapse-free cure. WP8 will guide the prioritization of treatment regimens and optimized design for phase 2C/3 clinical trials.
Leading partners
Work Package 9
Digital adherence technology interventions
The overall aim of WP9 is to explore, define, prepare, implement and refine a digital adherence technology (DAT) intervention to measure and ensure maximal adherence throughout the phase 2B/C studies.
Leading partners
Work Package 10
Data and biosample sharing
The overall aim of WP10 is to coordinate the acquisition, curation, standardization, and integration of de-identified patient-level data and preclinical research data and provide secure access through a data collaboration platform. WP10 will also be responsible for the human sample biobank.
Leading partners
Work Package 11
Implementation, dissemination & communication
The overall aim of WP11 is to reach and engage with key stakeholders in the field of TB care and control. WP11 will also share the scientific results, best practices, policy recommendations, and other insights learned throughout the course of the project.
Leading partners
Work Package 12
Ethics & data privacy
The overall aim of WP12 is to ensure that potential ethics and data privacy issues are actively monitored and dealt with accordingly. WP12 is responsible for the setup & management of an Ethics Advisory Board and a Data Management Committee for the data collaboration platform (WP10)
Leading partners