Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance
Open Access
- 6 September 2019
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLoS Medicine
- Vol. 16 (9), e1002915
- https://doi.org/10.1371/journal.pmed.1002915
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.This publication has 20 references indexed in Scilit:
- Assessment of treatment response in tuberculosisExpert Review of Respiratory Medicine, 2016
- A new trial design to accelerate tuberculosis drug development: the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP)BMC Medicine, 2016
- Adaptive clinical trials in tuberculosis: applications, challenges and solutionsThe International Journal of Tuberculosis and Lung Disease, 2015
- FDA Approval of Bedaquiline — The Benefit–Risk Balance for Drug-Resistant TuberculosisThe New England Journal of Medicine, 2014
- Too Much Information — The Ethics of Self-DisclosureThe New England Journal of Medicine, 2014
- Tuberculosis Biomarker and Surrogate Endpoint Research RoadmapAmerican Journal of Respiratory and Critical Care Medicine, 2011
- Biomarkers for tuberculosis disease activity, cure, and relapseThe Lancet Infectious Diseases, 2010
- Going from evidence to recommendationsBMJ, 2008
- Challenges in tuberculosis drug research and developmentNature Medicine, 2007
- Influence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug ProjectThe New England Journal of Medicine, 1980