Defining efficacy endpoints for late phase tuberculosis treatment non-inferiority trials
Randomised trials of new TB treatment regimens use a non-inferiority design, comparing new regimens to the established standard of care. In the last 20-years, these trials have used a composite primary endpoint which has included events such as treatment failure, relapse, death, early discontinuation of treatment, loss to follow-up, and treatment switches. We believe this approach should be abandoned in favour of an efficacy endpoint comprising only treatment failure and relapse.
Speakers
Daniel Grint
Daniel Grint is an Associate Professor of Medical Statistics and Epidemiology at the London School of Hygiene and Tropical Medicine. He is a statistician and clinical trialist engaged in the design, analysis, and methodology of randomised controlled trials and observational studies in the field of tuberculosis and HIV.
Tom Yates
Tom Yates is an infectious diseases registrar and epidemiologist. He is currently an NIHR clinical lecturer in the Institute of Health Informatics at UCL. His research interests include tuberculosis and CMV.
Chair
Professor Richard White, LSHTM
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