Working closely with the Data Standards and Integration Workgroup (DSI-WG), the M&S-WG uses aggregated clinical trial data to create robust empirical, mechanistic, and systems biology models and quantitative simulation tools to facilitate TB drug and drug regimen development.
The DSI-WG provides the information technology (IT) infrastructure to support all CPTR data needs for developing regulatory science tools and methods to enable development of new TB drugs, drug regimens, and diagnostics. Aggregating all relevant data in a secure database for analysis by the CPTR Workgroups and authorized researchers is a key focus for this […]
The PCS-WG is focused on the evidence-based evaluation of translational tools to support effective decision-making and advance new agents from the pre-clinical to clinical development space. These tools represent innovative approaches to address pre-clinical issues, including pre-clinical in vitro and in vivo efficacy, pre-clinical drug safety, and toxicology, pre-clinical PK/PD analyses involving the use of […]
The BCE-WG identifies, develops consensus, and builds the evidence base to submit potential biomarkers and clinical endpoints that have promise in the development of new TB medical products to FDA and EMA for regulatory review and qualification in a specific context of use when applicable.
The ENS-WG mission is to focus on discovery and validation of the molecular basis for resistance and correlation of resistance to clinical outcome. Objectives: Discover relevant drug resistant mutations for potential use in molecular assays. Correlate genetic resistance mutations with phenotypic resistance and clinical outcomes. Optimize phenotypic assays. Review existing genotypic, phenotypic or animal data […]
The AYD-WG’s focus is a DST for implementation at the microscopy center level or above. The work group also continues to monitor clinical drug trials to determine when and what changes need to be made to current Target Product Profiles (TPP’s) that have been developed. The AYD-WG is coordinating with academic partners, product development partnerships […]
The SRV-WG is defining the magnitude and trends of drug resistance in high burden countries, with particular focus on new and existing drugs for which resistance surveillance data are largely unavailable. Furthermore, the SRV-WG will explore the development of novel strategies for surveillance of TB drug resistance based on high-throughput molecular technologies.
Provide a one-stop data source for clinically relevant genotypic and phenotypic information on Mycobacterium tuberculosis (Mtb). This data, reviewed, validated, and accessible in one place, will support the development of new tests which can rapidly inform appropriate therapy for TB patients.
The Stakeholder and Community Engagement Workgroup (SCE-WG) facilitates the development of regimens by early, effective, and appropriate collaboration of key stakeholders and by building awareness and support among communities. The ability to successfully engage the community while conducting clinical trials is an essential component for regimen development.
The Global Regulatory Pathways Workgroup (GRP-WG) identifies efficiencies in the regulatory pathway to develop a novel regimen by fostering dialogue among key regulatory agencies, the WHO, and National Tuberculosis Programs (NTPs). This Workgroup develops pathways for regulatory approval that incentivize regimen development. Regulators from countries or regions with high TB burden are included in this […]