The results one of the largest and most rigorous tuberculosis (TB) drug trials ever conducted in the modern era, led by researchers at the University of St Andrews, will be made available to the wider research community from today (18 April 2016) with the launch of a new data-sharing platform.
The TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS) will curate, validate and improve access to clinical trial data – enabling the development of drug regimens which will ultimately benefit TB patients.
TB is the world’s leading infectious killer, with nearly nine million people newly diagnosed with TB each year. However significant side-effects and six-month treatment times make it difficult for many patients to complete therapy. Failure to complete treatment is a major driver of the emergence of multi-drug resistant TB (MDR-TB), which requires substantially longer, more complicated and expensive treatment.
Researchers will now have access to patient-level data from the REMoxTB trial led by Professor Stephen Gillespie, Sir James Black Chair of Medicine at the University of St Andrews, which was among the most rigorous TB drug trials ever conducted in the modern era.
In a world first, this data will be combined with a wealth of clinical trial data from the World Health Organisation (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), St George’s University of London, and other organizations – including data from the OFLOTUB and RIFAQUIN clinical trials. This is the first time clinical trial sponsors have worked together to make clinical trial data collectively available to the research community.
Having the data available in this aggregated form, it may be possible to detect patterns not otherwise apparent in individual datasets. Data from the individual studies can be separated if needed, and additional trial data can be shared in the future.
Professor Gillespie commented: “This is an important milestone for clinical trials of tuberculosis.
“By sharing patient-level data with researchers around the globe we will multiply the value of the data that has been donated by patients to clinical trials – maximising the significance of their contributions to battling TB.”
Martha Brumfield, President and CEO of C-Path (a not-for-profit international leader in catalysing medical innovation, and lead partner in the TB-PACTS project), said: “By combining C-Path’s core strengths in data aggregation, standardisation and curation with a wealth of clinical trial data from TDR, TB Alliance, St George’s University of London, and other organizations, we strive to enable more efficient and effective drug development for TB. We envision TB-PACTS as a prime example of how a collaborative, data-sharing approach leads to a knowledge base greater than the sum of its parts.”
TB-PACTS is a data-sharing platform launched by The Critical Path Institute (C-Path), the WHO Special Programme for Research and Training in Tropical Diseases (TDR), TB Alliance, and St George’s University of London.
The REMoxTB, RIFAQUIN and OFLOTUB clinical trials were sponsored, respectively, by: TB Alliance, St George’s University of London, and WHO TDR.
The REMoxTB study was a collaboration between the TB Alliance, Bayer HealthCare AG, University College London (UCL) Centre for Clinical Microbiology, the Medical Research Council Clinical Trials Unit at UCL, and the University of St Andrews. It enrolled 1931 patients at 50 sites in nine countries (Kenya, Mexico, Tanzania, South Africa, China, India, Thailand, Malaysia and Zambia).
Researchers applying for access 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.