WHO lists the tools we need for developing better TB treatments
22 July 2021
The WHO has just published a 'Position statement on innovative clinical trial design for development of new TB treatments'. The work of UCL-TB members has contributed to the discussions and evidence base that led to these guidelines.
Treating TB is still slow, with significant problems of side-effects to patients, and a continuous battle against drug-resistance. Testing new options in clinical trials is also slow, complex and expensive.
In order to focus the minds of all the players involved - governments, policy makers, NGOs, pharmaceutical companies, researchers, and more - the World Health Organization has just published a 'Position statement on innovative clinical trial design for development of new TB treatments'.
This short document describes 'key clinical trial characteristics to help advance novel therapies', and highlights:
- pharmacological models to predict the informing the best drug combinations and doses to use - and moving beyond predicted efficacy, to safety, variability in patients, and adherence to treatment
- the development of a collection of biomarkers for monitoring different aspects of trial efficacy to allow decisions to be made more quickly about the progress of the trial
- novel clinical trial designs that are more flexible
- continuing to collect evidence after a drug regimen is approved, for example to look at groups not focused on in the main trial.
The work of UCL-TB members has contributed to the discussions and evidence base that led to these guidelines. The references include:
Clinical trial design:
Treatment of highly drug-resistant pulmonary tuberculosis. (2020) Conradie, F., A. H. Diacon, N. Ngubane, P. Howell, D. Everitt, A. M. Crook, C. M. Mendel, E. Egizi, J. Moreira, J. Timm, T. D. McHugh, G. H. Wills, A. Bateson, R. Hunt, C. Van Niekerk, M. Li, M. Olugbosi, M. Spigelman and T. B. T. T. Nix. N Engl J Med 382(10): 893-902 https://doi.org/10.1056/NEJMoa1901814
The Molecular Bacterial Load Assay Replaces Solid Culture for Measuring Early Bactericidal Response to Antituberculosis Treatment. (2014) Honeyborne, I., B. Mtafya, P. P. J. Phillips, M. Hoelscher, E. N. Ntinginya, A. Kohlenberg, A. Rachow, G. Rojas-Ponce, T. D. McHugh, N. Heinrich and P. A. C. Evaluation. Journal of Clinical Microbiology 52(8): 3064-3067 https://doi.org/10.1128/Jcm.01128-14