Fabiane, Stella Maris;
Hakiman, Assica;
Schumacher, Samuel;
Mirzayev, Fuad;
Rangaka, Lele;
Goodall, Ruth;
(2024)
Data sharing experiences from the publicly accessible WHO TB-IPD platform.
Presented at: 7th International Clinical Trials Methodology Conference (ICTMC), Edinburgh, UK.
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Abstract
Introduction: In 2021 the WHO Global TB programme published a call for expressions of interest (WHO 2021) in setting up a new platform for aggregating and sharing individual patient data (IPD) on drug-resistant tuberculosis (DR-TB). The aim was that this would lead to new knowledge through research, contribute to evidence-informed guideline development, and would provide open and equitable access to the data to researchers. Such data are collected regularly by WHO for TB Guideline Development but to date have not been curated into a permanent collection to share more widely. Two previous DR-TB IPDs have been developed, each containing ~10,000 records, and meta-analyses published (Ahuja et al. 2012, Ahmad et al. 2018). However, these were not set up or intended for access beyond the research group responsible for data collection. UCL were appointed as the initial Data Curators for this new WHO DR-TB IPD. / Methods: Developing governance and processes for the data transfers is a major task. We looked at similar platforms for examples of good practice, such as the Infectious Diseases Data Observatory and TB-PACTS and had discussion with ICOMS, the ICO and data protection lawyers. The IPD has been set up within UCL’s Data Safe Haven computing environment, which is designed for securely storing, handling and analysing identifiable data. Work has been undertaken to develop a standardised data dictionary for contributed datasets. We have expanded to incorporate clinical trial as well as paediatric data and drug-sensitive TB. / Results: We are currently reaching the end of the process of working with the existing data curators to transfer existing datasets to UCL where the original data contributors have agreed. A similar process is being followed to bring in data submitted to WHO in 2021 for guideline development, and for new datasets from more recent studies. The IPD currently contains data from 48 studies on 35,767 participants. We have received 4 requests for data. / Discussion: One of the most challenging parts of this process was to develop a Data Sharing Agreement that is detailed yet generic enough to satisfy data contributors from different countries and different types of organisation (e.g. academia, pharmaceutical companies, national treatment programs). Issues have arisen from country-specific interpretation of GDPR and varying definitions of anonymised and pseudonymised data. Sharing data with profit-making organisations is another problem that often arises when discussing data inclusion with contributors.
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