Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance
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.
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| Veröffentlicht in: | PLoS medicine 2019-09, Vol.16 (9), p.e1002915 |
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| creator | Lienhardt, Christian Vernon, Andrew A Cavaleri, Marco Nambiar, Sumati Nahid, Payam |
| description | 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. |
| doi_str_mv | 10.1371/journal.pmed.1002915 |
| format | Article |
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Licensee Public Library of Science. This is an open access article distributed under the Creative Commons Attribution IGO License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/license: http://creativecommons.org/licenses/by/3.0/igo/ (the “License”)s/by/3.0/igo/. In any use of this article, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL. 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| subjects | Analysis Antitubercular Agents - adverse effects Antitubercular Agents - therapeutic use Bedaquiline Biomarkers Care and treatment Clinical trials Clinical Trials as Topic - methods Collection Review Data collection Development and progression Disease Drug approval Drug Approval - methods Drug resistance Endpoint Determination FDA approval HIV Human health and pathology Human immunodeficiency virus Humans Immunology Infectious diseases Life Sciences Logos Medicine and Health Sciences Pharmaceutical sciences Pharmacology Policy Making Public Health Research and Analysis Methods Research Design Risk factors Santé publique et épidémiologie Science Policy Treatment Outcome Tuberculosis Tuberculosis - diagnosis Tuberculosis - drug therapy Tuberculosis - microbiology Vaccinology |
| title | Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance |
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