PLOS Medicine Special Collection on Advances in Clinical Trial Design for Development of New Treatments for TB
06 March 2020 | GENEVA -- A Special Collection on Advances in Clinical Trial Design for Development of New Treatments for Tuberculosis has been released by PLOS Medicine. This Special Collection, that is now complete with the publication of its last paper, contains a series of articles that articulate the essential new steps in clinical research that will pave the way for the development of future optimal treatment for all forms of tuberculosis. The Collection has been sponsored by the World Health Organization (WHO) and the French National Research Institute for Sustainable Development (IRD-France), and coordinated by Dr Christian Lienhardt, Research Director at IRD-France and Dr Payam Nahid, Professor at University of California, San Francisco, USA
Development of new TB treatments is very long and costly, and
hampered by several methodological limitations. The most
commonly touted challenge in TB therapeutics remains the absence
of a surrogate marker that can be readily measured and that
estimates with adequate certainty the anticipated treatment
effect in late stage clinical development. New opportunities are
emerging with the recent developments in pharmacokinetics and
pharmacodynamics methodologies, novel clinical trial designs,
new biomarkers, as well as recent advances in molecular
diagnostics. A recently broadened and exciting pipeline of new
candidate drugs compels us to revisit our current approaches to
TB drug development, and based on the learnings of the last 50
years, to identify and seek consensus on best practices for
future TB clinical trial designs.
“There is a profound need for harmonized approaches to
regimen development to ensure that best practices are used to
accelerate development of new TB regimens”, said Dr Tereza Kasaeva, Director, WHO Global TB Programme.
“By using innovative approaches such as those outlined
in this Collection, we hope that the next generation of TB
trials will yield high-quality evidence for novel regimens
that meet the needs of the millions who fall ill with TB each
year.”
The PLOS Medicine Collection builds on the outputs of a
technical consultation organized by WHO on “Advances in Clinical Trial Design for New TB Treatments” to identify and outline, through expert consensus, the
optimal characteristics of clinical trial designs to inform
policy guidance for the development of new TB regimens.
“We are at an unprecedented cross point at which reflections
on a rich history of clinical trials meet new advances in
methodological methods and technologies to move forward
research and approaches for new TB treatments”, said Christian Lienhardt, Research Director at
IRD-France. “With increasing opportunities to test various
combinations of new and repurposed drugs, novel trial designs
will likely accelerate the development of new TB
treatments”.
Source:
WHO
