TB Platform for the Project to Accelerate New Treatments for Tuberculosis (PAN-TB)
The PAN-TB data platform is designed to catalyze and accelerate 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 Data Platform 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 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 Data Platform Partnership:
This initiative represents a collaborative partnership between Bill and Melinda Gates Foundation (BMGF), Bill and Melinda 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:
Creation of the PAN-TB data platform was made possible by grant funding from the Bill and Melinda Gates Foundation.
The PAN-TB Data Repository resides on an EU-based data archive platform; the data archive was made possible through funding from the Bill & Melinda Gates Foundation (BMGF) and is currently being supported by funding from the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The purpose of the data archive is to catalyze and accelerate research by curating and standardizing clinical trial and preclinical experimental data and making this data available to qualified researchers.
PAN-TB Data Platform Content:
The PAN-TB data platform 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.
Request a Login: Please, click here for further details and guidance regarding the hosted platform.
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 |
Important Information
The platform 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.
- 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 PAN-TB Data Platform is available to qualified researchers who have submitted a sound TB research proposal, have agreed to the “PAN-TB Terms and Conditions for Data Use”, and have been approved through the PAN-TB access review process.
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 the PAN-TB Data Platform:
| 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 FAQs
There is no fee to use the PAN-TB data platform.
We appreciate suggestions on improvements to the PAN-TB data platform. Please send your comments and suggestions to: codr-eu@c-path.eu.
The platform 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 registered users of the PAN-TB data platform.
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
Visit the Data Archive Platform page on this website to register for access. You must first review and agree to the Terms and Conditions for Use of the PAN-TB data platform. Once completed, researchers will be directed to 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.
PAN-TB 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.