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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Bibliographische Detailangaben
Veröffentlicht in:	PLoS medicine 2019-09, Vol.16 (9), p.e1002915
Hauptverfasser:	Lienhardt, Christian, Vernon, Andrew A, Cavaleri, Marco, Nambiar, Sumati, Nahid, Payam
Format:	Artikel
Sprache:	eng
Schlagworte:	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
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Beschreibung
Zusammenfassung:	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.
ISSN:	1549-1676 1549-1277 1549-1676
DOI:	10.1371/journal.pmed.1002915