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To commemorate World TB Day, a special collection has been published by PLOS Medicine contains a series of articles that articulate critical new steps in clinical research that will pave the way for the development of tomorrow's optimal treatment for all forms of TB. This special collection is sponsored by the World Health Organization (WHO) and the National Research Institute for Sustainable Development (IRD-France) and is coordinated by Dr. Christian Lienhardt, Director of Research at IRD- France, and Dr. Payam Nahid, professor. at the University of California, San Francisco, USA.
This series is the result of a technical consultation organized by WHO on March 11 and 13, 2018 on the theme "Advances in the design of clinical trials for new anti-tuberculosis treatments." Identify and describe, by consensus among experts, the characteristics Optimal Clinical Trial Designs Based on lessons learned from the rich history of TB clinical trials, the experts reviewed the various models and tools currently used in the conduct of clinical trials and trials. have formulated a series of proposals to advance the field, "In order to accelerate the development of new TB treatments, it is essential to maximize the sharing of data and experiences and to improve the design of clinical trial, "says Dr. Matteo Zignol, Team Leader, Tuberculosis Research, Elimination, Global Program to Combat tuberculosis, WHO.
A series of iterative clinical trials undertaken in the 1970s and 1980s by the British Medical Research Council and the United States Public Health Services established the modern six-month treatment regimen for tuberculosis sensitive to drugs. Since then, despite the arrival on the market of two newly approved drugs, progress in reducing the duration of antituberculosis treatment and improving the tolerability of antituberculosis treatment regimens has been excessively slow, the treatment of resistant tuberculosis drugs always based on a complex drug, poorly tolerated. combination of drugs administered for a period of 9 to 20 months.
The development of new TB treatments will continue to be hampered by many challenges, ranging from laboratory to mycobacteriology for the definition of endpoints, to the area in which a clinical trial control group must be selected and implemented. given the rapid political evolution. The most commonly reported challenge for TB treatment is the absence of a surrogate marker that can be easily measured and that can be used to estimate with sufficient certainty the expected effect of treatment at the advanced clinical stage. New opportunities are emerging with recent developments in PK / PD methodologies, new clinical trial designs, new biomarkers, and recent advances in molecular diagnostics. A recently expanded and exciting portfolio of new drug candidates forces us to review our current approaches to TB drug development, and building on the lessons of the past 50 years, to identify and seek consensus on best practices for future models. of tuberculosis clinical trials. We are at an unprecedented turning point where reflections on a rich history of clinical trials are seeing new advances in methodological methods and technologies to advance research and approaches for new antituberculous treatments, says Dr. Christian Lienhardt.
the PLOS Medicine The special collection, launched on March 22, 2019, presents a series of articles describing the new essential steps in clinical research that will pave the way for the development of the optimal treatment of tomorrow for all forms of tuberculosis.
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