Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance

Christian Lienhardt; Andrew A Vernon; Marco Cavaleri; Sumati Nambiar; Payam Nahid

doi:10.1371/journal.pmed.1002915

Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance

PLoS Med. 2019 Sep 6;16(9):e1002915. doi: 10.1371/journal.pmed.1002915. eCollection 2019 Sep.

Authors

Christian Lienhardt¹, Andrew A Vernon², Marco Cavaleri³, Sumati Nambiar⁴, Payam Nahid⁵

Affiliations

¹ Unité Mixte Internationale TransVIHMI, UMI 233 IRD-U1175 INSERM-Université de Montpellier, Institut de Recherche pour le Développement (IRD), Montpellier, France.
² Division of TB Elimination, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
³ Office of Anti-infective and Vaccines, Human Medicines Evaluation, European Medicines Agency, Amsterdam, the Netherlands.
⁴ Division of Anti-Infective Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America.
⁵ Division of Pulmonary and Critical Care Medicine, Center for Tuberculosis, University of California, San Francisco, San Francisco, California, United States of America.

Abstract

Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.

Publication types

Review

MeSH terms

Antitubercular Agents / adverse effects
Antitubercular Agents / therapeutic use*
Biomarkers
Clinical Trials as Topic / methods*
Drug Approval / methods*
Endpoint Determination*
Humans
Policy Making
Public Health*
Research Design*
Treatment Outcome
Tuberculosis / diagnosis
Tuberculosis / drug therapy*
Tuberculosis / microbiology

Substances

Antitubercular Agents
Biomarkers

Grants and funding

No specific funding was received for this study. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.