Close
The project
The TB-IPD platform is a WHO Global TB Programme initiative, contracted initially to University College London for the first 5 years.
The goal of the IPD is to increase the knowledge base for normative guidance on optimal treatment modalities for TB and stimulate TB research. This will be done both by aggregating Individual Patient Data where possible into a single dataset, and also by encouraging and facilitating scientists to develop novel research proposals that make use of the data.
The TB-IPD Platform will house individual patient data which is effectively anonymised. The term ‘effectively anonymised’ refers to data which: (i) does not relate to an identified or identifiable individual; or (ii) has been rendered anonymous in such a way that individuals are not (or are no longer) identifiable. Data held by UCL within the TB-IPD will also be stored securely so that the risk of indirect re-identification is very low.
Although the initial concept note proposed an IPD that focused on drug-resistant TB or observational data, we now believe that this a priori limitation in scope is not required. We are in principle open to include data on drug-resistant or drug-sensitive TB, regardless of study design. The platform will also expand to hold TB treatment data in pregnancy and paediatrics (made possible by engagement with Stellenbosch University). The patient data to be provided will come from a range of relevant global resources, including researchers, local and national databases relating to TB and development and public health research and surveillance projects. We plan to extend the IPD to include data from clinical trials in TB which would be stored alongside the observational data but not be pooled.
This project builds on two IPDs set up, managed and analysed at McGill University under the direction of Dr Dick Menzies.
Our team
UCL team
Project leads: Prof Molebogeng (Lele) Rangaka & Dr Ruth Goodall
Data Management: Dr Stella Fabiane
Asset Administrator: Assica Hakiman
Communications lead: Lydia Walker
WHO team
Medical Officer and Treatment Team Lead: Dr Fuad Mirzayev
Scientist: Dr Samuel Schumacher
Medical Officers: Dr Medea Gegia & Dr Linh Nhat Hguyen
Governance
We work within the framework of research governance policies and procedures adopted by UCL to ensure that research is carried out legally, ethically and with integrity.
The governance of this project is encompassed in:
- Ethical and data protection impact assessments reviewed and approved by the UCL Research Ethics Committee
- Legal agreements (Data Sharing Agreement, Data Access Agreement) between UCL and Data Contributors and researchers
- Procedures for review and oversight
- Secure handling and storage of data
We have in place a structure and process that includes oversight provided by a Data Access Committee and a Steering Committee. Membership to these committees is on a rolling basis.
Data Access Committee
The committee with responsibility for reviewing and accepting or rejecting applications for data access. It will be comprised of a combination of Data Contributors, the WHO and UCL, and other stakeholders as deemed appropriate;
- Professor Anneke Hesseling (Stellenbosch University, South Africa)
- Professor Salmaan Keshavjee (Harvard Medical School, USA)
- Dr Norbert Ndjeka (National Department of Health, South Africa)
- Dr Carla Winston (Centers for Disease Control, USA)
- Dr Bern-Thomas Nyang’wa (Médecins Sans Frontières, Netherlands)
- Dr Ezio Távora dos Santos Filho (REDE-TB - Brazilian TB Research Network, Brazil)
Data Access Committee Terms of Reference
Data Access Committee meetings for the year 2023:
- 2nd meeting: 1st September 2023
- 3rd meeting: 29th November 2023
Steering Committee
The Steering Committee have responsibility for oversight and coordination of the TB-IPD Platform.