Approval of a tuberculosis drug based on a paradoxical surrogate measure

JAMA. 2013 Apr 3;309(13):1349-50. doi: 10.1001/jama.2013.623.

Author

Affiliation

¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA. javorn@medsoc.harvard.edu

PMID: 23430122
DOI: 10.1001/jama.2013.623

No abstract available

MeSH terms

Antitubercular Agents / adverse effects
Antitubercular Agents / therapeutic use*
Biomarkers*
Diarylquinolines
Drug Approval*
Drug Industry
Drug Labeling
Humans
Long QT Syndrome / chemically induced
Mycobacterium tuberculosis / isolation & purification
Quinolines / adverse effects
Quinolines / therapeutic use*
Randomized Controlled Trials as Topic
Sample Size
Sputum / microbiology
Tuberculosis, Multidrug-Resistant / drug therapy*
United States
United States Food and Drug Administration

Substances

Antitubercular Agents
Biomarkers
Diarylquinolines
Quinolines
bedaquiline