Medicine & Health

Advances in Clinical Trial Design for Development of New Treatments for Tuberculosis

Published June 30, 2020 Partnered Collections, Special Issues

With recent opportunities to test combinations of new and repurposed drugs for the treatment of TB, new questions arise for optimal clinical trial design. To address these, in March 2018 WHO organized a consultation on “Advances in Clinical Trial Design for New TB Treatments” to identify and outline the optimal characteristics of clinical trial designs to inform policy guidance for new TB regimens. This PLOS Medicine Special Collection assembles a series of articles on current reflections and describes essential new steps in clinical research that will pave the way for the development of tomorrow’s optimal treatment for all forms of TB.

Image Credit: U.S. Centers for Disease Control and Prevention - Medical Illustrator_Public_Domain

Jump to section

Introduction
Definition of new regimens: early clinical development
New trial designs and how they may facilitate regimen development
Considering subjects: trial adherence and special populations
From trials to guidance: bringing evidence to best programme and practice
Conclusion

Introduction

Image credit
TeroVesalainen, Pixabay

PLOS Medicine Advances in clinical trial design for development of new TB treatments: A call for innovation
March 22, 2019 Christian Lienhardt, Payam Nahid

Definition of new regimens: early clinical development

Image credit
10.1371/journal.pmed.1002842

PLOS Medicine Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology
July 5, 2019 Kelly E. Dooley, Debra Hanna, Vidya Mave, Kathleen Eisenach, Radojka M. Savic
Image credit
10.1371/journal.pmed.1002851

PLOS Medicine Accelerating the transition of new tuberculosis drug combinations from Phase II to Phase III trials: New technologies and innovative designs
July 9, 2019 Geraint Davies, Martin Boeree, Dave Hermann, Michael Hoelscher

New trial designs and how they may facilitate regimen development

Image credit
Patrick P. J. Phillips et al

PLOS Medicine Keeping phase III tuberculosis trials relevant: Adapting to a rapidly changing landscape
March 22, 2019 Patrick Phillips, Carole Mitnick, James Neaton, Payam Nahid, Christian Lienhardt, Andrew Nunn
Image credit
10.1371/journal.pmed.1002850

PLOS Medicine Designing noninferiority tuberculosis treatment trials: Identifying practical advantages for drug regimens with acceptable effectiveness
July 12, 2019 Piero L. Olliaro, Michel Vaillant

Considering subjects: trial adherence and special populations

Image credit
10.1371/journal.pmed.1002884

PLOS Medicine The importance of adherence in tuberculosis treatment clinical trials and its relevance in explanatory and pragmatic trials
December 10, 2019 Andrew Vernon, Rada Savic, Katherine Fielding, Lori Dodd, Payam Nahid
Image credit
10.1371/journal.pmed.1002882

PLOS Medicine Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons
August 15, 2019 Amita Gupta, Michael Hughes, Anthony Garcia-Prats, Katherine McIntire, Anneke Hesseling

From trials to guidance: bringing evidence to best programme and practice

Image credit
10.1371/journal.pmed.1002915

PLOS Medicine Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance
September 6, 2019 Christian Lienhardt, Andrew Vernon, Marco Cavaleri, Sumati Nambiar, Payam Nahid
Image credit
10.1371/journal.pmed.1002896

PLOS Medicine Advances in clinical trial design for development of new TB treatments—Translating international tuberculosis treatment guidelines into national strategic plans: Experiences from Belarus, South Africa, and Vietnam
October 18, 2019 Grania Brigden, Nguyen Nhung, Alena Skrahina, Norbert Ndjeka, Dennis Falzon, Matteo Zignol

Conclusion

Image credit
10.1371/journal.pmed.1003059

PLOS Medicine Advances in clinical trial design: Weaving tomorrow’s TB treatments
February 27, 2020 Christian Lienhardt, Andrew Nunn, Richard Chaisson, Andrew Vernon, Matteo Zignol, Payam Nahid, Eric Delaporte, Tereza Kasaeva

PDF

Read and download the Collection PDF.

Download

PLOS|Speaking of Medicine TB Blog

To coincide with #WorldTBDay2019, six survivors from diverse backgrounds describe how tuberculosis wreaked havoc on their lives and drove them to advocate at a local and global level to improve care and end the suffering caused by the disease.

PLOS Channels & Collections Blog

PLOS Special Collection Partner

French National Research Institute for Sustainable Development | World Health Organization