TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS)

• The data platform contains, but is not limited to:
  • Drug susceptibility data
  • Demographic data
  • MTB diagnostic testing results
  • Concomitant medications information
  • Adverse event information
  • Treatment adherence information
  • Co-morbidities
  • Treatment outcomes
  • HIV co-infection information
  • CD4 counts
  • TB disease symptoms

• All data has been anonymized by the contributor.
• Researchers must agree to the Terms and Conditions for Use of the TB-PACTS data platform and submit an online application form to request access to the data platform.
• The TB-PACTS data platform Steering Committee approves data access for external users.
• The Resources tab within the data platform contains information to help users understand and make use of the platform capabilities.

• C-Path has normalized all data to the CDISC TB-specific Study Data Tabulation Model (CDISC SDTM) to enable researchers to analyze the data in aggregate.
• The TB-PACTS data platform provides basic information on how data are structured using CDISC. Knowledge of SDTM is required for effective use of the data. More information and training about SDTM is available through the CDISC website. Researchers can find further information by accessing the CDISC website here.

A summary of detailed concepts captured by SDTM domains contained in the TB-PACTS data platform database is provided in the table below.

We appreciate suggestions on improvements to the TB-PACTS data platform. Please send your comments and suggestions to Richard Liwski (rliwski@c-path.org).

The TB-PACTS data platform contains TB clinical study data, which includes demographic information, concomitant medications information, dose/concentration information, outcomes data, and relevant covariates of interest. Additional information specific to data content will be available to registered users of the TB-PACTS data platform.

The data are mapped to the Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM), and TB-specific Therapeutic Area User Guide (v2) to maximize utility of aggregated data for statistical analysis. All data are fully anonymized.

Visit the Data Archive Platform on this website to register for access. You must first review and agree to the Terms and Conditions for Use of the TB-PACTS data platform.  Once completed, researchers will be directed to the online application form.

The TB-PACTS steering committee will review all user access applications in a timely manner and this may take up to 4 weeks to process.

Individuals, organizations, institutions, and countries (health ministries, national TB programs, etc.) are encouraged to contribute 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.

TB-PACTS 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 encryption, de-identification, and anonymization
• 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.