Abstract
Christian Lienhardt and co-authors discuss the conclusions of the PLOS Medicine Collection on advances in clinical trial design for development of new tuberculosis treatments.
Highlights
In Homer’s Odyssey, each night, Penelope unwove the tapestries she made in the day to delay her marriage to one of the contenders for Ulysses’ throne while awaiting his return
The development process for new tuberculosis (TB) regimens remains slow and costly. In this concluding paper of the PLOS Medicine Special Collection, we highlight the key suggestions made at a WHO Technical Consultation on “Advances in Clinical Trial Design for Development of New TB Treatments” held in 2018 to address this challenge
We offer an assessment of challenges and dogma addressed by the WHO Technical Consultation on “Advances in Clinical Trial Design for Development of New TB Treatments” that took place in Glion-sur-Montreux, Switzerland, March 14–16, 2018 [8]
Summary
The development process for new tuberculosis (TB) regimens remains slow and costly. In this concluding paper of the PLOS Medicine Special Collection, we highlight the key suggestions made at a WHO Technical Consultation on “Advances in Clinical Trial Design for Development of New TB Treatments” held in 2018 to address this challenge. The integration of extended posttreatment follow-up with collection of real-time treatment outcomes in the new hybrid Phase IIC design, with features drawn from both Phase II and Phase III trials, permits earlier identification of candidate regimens likely to succeed in Phase III. We advocate here for a better systematization and harmonization of the approaches taken internationally to ensure that best practices and novel research designs are used to accelerate development of new TB regimens.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
