PreDiCT-TB: Model-based preclinical dev. of TB drug combinations v1
Research type
Research Database
Full title
Predict-TB: Model-based preclinical development of anti-TB drug combin
IRAS ID
126668
Contact name
Kevan Ryan
Contact email
Research summary
PreDiCT-TB: Model-based preclinical dev. of TB drug combinations v1
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0093
Date of REC Opinion
5 Mar 2014
REC opinion
Favourable Opinion
Data collection arrangements
The PreDiCT-TB Database of TB Trials (DoTT) aims to assemble a comprehensive repository of selected data from historical, ongoing and future clinical trials of combinations of drugs for treatment of tuberculosis. In the first phase of the project aggregated summary level data from publications will be assembled followed by requests for individual participant data from the data custodians of the individual trials, if they exist.Data collection procedures will aim to ensure that original consent procedures do not preclude re-use and were conducted in an appropriate manner. These data will include data on basic participant characteristics, some laboratory tests, blood drug concentrations, results of bacteriology during treatment and long-term clinical outcomes such as treatment failure, relapse and death. No personal data will be stored and all data will be stored in an irreversibly anonymised form to provide the highest degree of protection of privacy.
Research programme
The PreDiCT-TB consortium brings together internationally-respected TB scientists and physicians with expertise in the biology, immunology and imaging of the disease, as well as those specialising in the pharmacology and clinical trials.The consortium unites all EFPIA (European Federation of Pharmaceutical Industries and Associations) members currently active in tuberculosis discovery and development within Europe together with many of the foremost academic researchers in the field.The scientific goal of PreDiCT-TB is to find new ways of accelerating effective drug development in tuberculosis. Initially, data held by PreDiCT-TB will be provided by and shared between the members of the consortium in order to better understand how preclinical data and early clinical measures of effectiveness can help to predict long term outcomes of treatment. Collaborating researchers from outside the consortium can also access the data for TB related studies but must submit a proposal to the steering committee who will examine the case and decide on access accordingly. At the end of the project the DoTT database will be maintained as a resource for TB researchers, updated with new data as it is released and overseen by a data access committee comprising representation of all important stakeholders. --------------------------------------------------------------------------------
Research database title
PreDiCT-TB: Model-based preclinical dev. of TB drug combinations v1
Establishment organisation
The University of Liverpool
Establishment organisation address
Foundation Building
Brownlow Hill
Liverpool
L69 7ZX