TB Platform for the Project to Accelerate New Treatments for Tuberculosis (PAN-TB)
The PAN-TB datasets are designed to catalyze and accelerate tuberculosis (TB) research by curating and standardizing Pharmacokinetic and relapsing mouse model (RMM) study data and making this data publicly available to qualified researchers.
Overview
PAN-TB Mission:
PAN-TB is a collaborative effort to accelerate the identification of promising PAN-TB regimens for advancement through phase 2b/2c clinical trials. These PAN-TB regimens will be designed to have improved safety and tolerability, a shorter duration, and be simpler to use than existing treatment options. In addition, PAN-TB conducts non-clinical studies such as relapsing mouse model studies (RMM), which are important in evaluating TB drug regimens.
PAN-TB Partnership:
This initiative represents a collaborative partnership between the Gates Foundation, Gates Medical Research Institute (Gates MRI), Janssen Pharmaceutica (Janssen), GlaxoSmithKline Intellectual Property Development Limited (GSK), Otsuka Pharmaceutical Co Ltd (Otsuka), The Global Alliance for TB Drug Development, Inc (TBA), and Evotec International GmbH (Evotec).
Acknowledgements:
The development of the PAN-TB effort was made possible by grant funding from the Gates Foundation.
PAN-TB Content:
PAN-TB catalogs contemporary TB Pharmacokinetic and relapsing mouse model (RMM) datasets and makes these datasets available to qualified researchers. Additional trial data, including clinical trial data, is expected to be made available in the future.
For more information on PAN-TB or how your organization can contribute data, please contact: codr-eu@c-path.eu.
PAN-TB Database
| Study ID | Area | No. of Animals | Title | Drugs | Contributors | Study Type |
|---|---|---|---|---|---|---|
| EVT-FR_DMPKDA-20200002 | Tuberculosis Mouse Model | 156 | EVT-FR_DMPKDA-20200002 | GSK-286, GSK-2830, Bedaquiline, Delamanid, Moxifloxacin, OPC-167832, Pretomanid, Sutezolid, Pyrazinamide | EVOTEC | In Vivo |
| EV-LY-TBA2001 | Tuberculosis Mouse Model | 421 | EV-LY-TBA2001 | Bedaquiline, Pretomanid, Moxifloxacin, Pyrazinamide, Delamanid, Sutezolid, OPC-167832, GSK-286 | EVOTEC | In Vivo |
| EV-LY-TBA2002 | Tuberculosis Mouse Model | 425 | EV-LY-TBA2002 | Bedaquiline, Pretomanid, Moxifloxacin, Pyrazinamide, Delamanid, Sutezolid, OPC-167832, GSK-286, GSK-830 | EVOTEC | In Vivo |
| EVT-FR_DMPKDA-20210001 | Tuberculosis Mouse Model | 336 | EVT-FR_DMPKDA-20210001 | Bedaquiline, Delamanid, Ethambutol, GSK2556286, GSK3211830, Isoniazid, Moxifloxacin, OPC-167832, Pretomanid, Pyrazinamide, Rifampin, Sutezolid | EVOTEC | In Vivo |
| EVT-FR-DMPKDA-20220006 | Tuberculosis Mouse Model | 384 | EVT-FR-DMPKDA-20220006 | Bedaquiline, Delamanid, GSK2556286, GSK3211830, Quabodepistat, Pretomanid, Sutezolid, GSK3036656 | EVOTEC | In Vivo |
| EV-TL-TBa22001 | Tuberculosis Mouse Model | 701 | EV-TL-TBa22001 | Bedaquiline, Pretomanid, Moxifloxacin, Pyrazinamide, Delamanid, Sutezolid, OPC-167832, GSK-286, GSK-830, Rifampin, Isoniazid, Ethambutol | EVOTEC | In Vivo |
| EVT-FR_DMPKDA-2023007 | Tuberculosis Mouse Model | 96 | EVT-FR_DMPKDA-2023007 | Bedaquiline, Delamanid, GSK3036656, Isoniazid, Moxifloxacin, Pretomanid, Pyrazinamide, Rifapentine, Sutezolid, TBAJ-876 | EVOTEC | In Vivo |
| EV-TL-TBa23001 | Tuberculosis Mouse Model | 578 | EV-TL-TBa23001 | Bedaquiline, Pretomanid, Moxifloxacin, Pyrazinamide, Delamanid, Sutezolid, Quabodepistat, GSK2556286, GSK3036656, Rifampicin, Isoniazid, Ethambutol | EVOTEC | In Vivo |
| EV-TL-TBa23007 | Tuberculosis Mouse Model | 274 | EV-TL-TBa23007 | Bedaquiline, Pretomanid, GSK-656, Sutezolid, Moxifloxacin, Pyrazinamide, Rifapentine, Isoniazid, GSK-830, TBAJ-876, Delamanid | EVOTEC | In Vivo |
| EVT-FR_DMPKDA-202402 | Tuberculosis Mouse Model | 216 | EVT-FR_DMPKDA-202402 | TBAJ-876, Pretomanid, Quabodepistat, Sutezolid, GSK2556286, GSK3036656, TBD09, TBD11 | EVOTEC | In Vivo |
EV-TL-TBa24001 | Tuberculosis Mouse Model | 615 | EV-TL-TBa24001 | Bedaquiline, Pretomanid, Sutezolid, GSK2556286, TBAJ-876, Moxifloxacin, Quabodepistat, TBD09, TBD11, Isoniazid, Rifapentine, Pyrazinamide | EVOTEC | In Vivo |
| EV-TL-TBa24003 | Tuberculosis Mouse Model | 194 | EV-TL-TBa24003 | Bedaquiline, Pretomanid, TBAJ-876, Sutezolid, GSK2556286, GSK3036656, Moxifloxacin, Quabodepistat, Pyrazinamide | EVOTEC | In Vivo |
Important Information
These datasets are available via the C-Path Data Analytics Platform (CP-DAP). If you do not already have a CP-DAP account, please register at the CP-DAP login page. Once logged into CP-DAP, you can search and apply for access to the PAN-TB datasets.
PAN-TB datasets are available to qualified researchers who have submitted a sound TB research proposal, have been approved through the PAN-TB access request review process, and have agreed to the “PAN-TB Terms and Conditions for Data Use.”
PAN-TB contains preclinical TB trial datasets currently consisting of pharmacokinetic and relapsing mouse model (RMM) studies in CDISC standards, contributed by Evotec to C-Path, for use by qualified TB researchers.
With C-Path’s continued engagement with various TB research initiatives, additional preclinical and clinical trial data may be available in the future.
The database contains, but is not limited to data on:
- Treatments
- Drug Resistance
- Demographics
- Biospecimen Events
- Body Weight
- Disposition
- Pharmacokinetics Concentration
- Microbiology Specimen
- Biospecimen Events
- Trial Level Data
- Procedure Agents
Please note that in light of differences in experimental protocols and approaches per data contributor, the data listed above may vary per study. All data have been remapped to a common data standard such that data can be analyzed across all studies.
The data is mapped to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND), Standard Data Tabulation Model (SDTM), Animal Rule Guide (SENDIG-AR v1.0) and Pharmacogenomics/Genetics Guide (PGxIG v1). Knowledge of SDTM and SEND is required for effective use of the data. Information and training on SDTM and SEND are available on the CDISC website.
Selected domains contained in PAN-TB:
| CDISC Domain | Variables of Interest |
| DM | Age, Gender, Species, Strain, Trial Arm |
| MB | Culture Results (CFU) |
| BW | Body Weight of Animal |
| EX | Drug Name, Drug Dose, Route & Drug Strength |
| AG | Procedure Agent Name & Dose |
| PC | Concentration measurements for administered compounds and their metabolites |
| BE | Culture collection and storage information |
General Questions
There is no fee to use any of the PAN-TB data.
We appreciate suggestions for improvements to the PAN-TB datasets or the CP-DAP platform. Please send your comments and suggestions to: codr-eu@c-path.eu.
PAN-TB contains preclinical TB trial datasets currently consisting of pharmacokinetic and relapsing mouse model (RMM) studies in CDISC standards, contributed by Evotec to C-Path, for use by qualified TB researchers.
Additional information specific to data content will be available to approved registered users.
The data is mapped to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND), Standard Data Tabulation Model (SDTM), Animal Rule Guide (SENDIG-AR v1.0) and Pharmacogenomics/Genetics Guide (PGxIG v1) to maximize utility of aggregated data for statistical analysis.
Registration for Access Questions
Visit the C-Path Data Analytics Platform (CP-DAP) to register an account and to apply for access. Once you have a CP-DAP account, you can search for PAN-TB and request access via the online application form.
The PAN-TB Access Review Committee (PARC) will review all user access applications in a timely manner, and this may take up to four weeks to process.
Data Contribution Questions
Individuals, organizations, institutions, and countries (health ministries, national TB programs, etc.) are encouraged to contribute preclinical and clinical study data. In addition to the study dataset, submitting organizations will be requested to provide information regarding study methodology and demographic data for their submissions. For additional information please contact: codr-eu@c-path.eu.
Yes, data ownership is always retained by the data contributor.
The data platform policies for data transfer, validation, processing and access include the following features to ensure that the data are safe and secure:
- Secure file transfer
- OS hardening and security updates
- Host-based intrusion detection/prevention system
- Anti-malware protection
- Automated log monitoring and alert system
- Data access controls for incoming server, investigational database, analysis datasets
- Data backup and disaster recovery
- Data provenance – changes to data will be traceable and auditable throughout its lifecycle
- Multi-factor authentication
- Multi-tier network structure
- File integrity monitor
Multiple data formats can be accommodated including text, csv, xls or SAS transport files. Supporting information can be PDF, text, Microsoft Word or other document formats. Critical Path Institute will provide guidance as needed to data contributors.
