Associate Professor of Medical Statistics and Epidemiology at the London School of Hygiene and Tropical Medicine. I am a clinical trialist engaged in the design, analysis, and statistical methods of randomised controlled trials and observational studies in the field of tuberculosis and HIV. My main research interest is the methodology of outcome definitions in late phase randomised controlled trials for new tuberculosis and HIV treatments.
Tuberculosis vaccine non-inferiority trials using an infection primary outcome must be designed and interpreted accounting for the specificity of the tests used to measure infection, otherwise they risk declaring non-inferiority by default. Until there is a test for TB infection with higher specificity than the interferon-gamma release assay, the use of the non-inferiority trial design for TB vaccine prevention of infection outcomes is not recommended.
Source: Conference 2024