Early Biomarkers and Regulatory Innovation in Multidrug-Resistant Tuberculosis | Zendy

Robert S. Wallis | Zendy; Thomas Peppard | Zendy

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Early Biomarkers and Regulatory Innovation in Multidrug-Resistant Tuberculosis

Author(s) -

Robert S. Wallis,

Thomas Peppard

Publication year - 2015

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/civ612

Subject(s) - medicine , tuberculosis , biomarker , clinical trial , sputum , drug development , intensive care medicine , multiple drug resistance , drug , marketing authorization , drug resistance , pharmacology , bioinformatics , pathology , microbiology and biotechnology , biochemistry , chemistry , biology

Biomarkers play an essential role in accelerating drug development. Sputum culture conversion using solid medium is the best-characterized tuberculosis biomarker, having been examined at the patient and trial levels in studies with thousands of subjects, and having recently been validated using data from 3 unsuccessful phase 3 trials. We presently are poised at the threshold of regulatory innovation for antibacterials to treat drug-resistant infections, in which Special Medical Use authorization restricted to patients with limited options could be based on the results of small clinical trials. Patients worldwide would be well served by licensing of new regimens for multidrug-resistant tuberculosis based on biomarker evidence commensurate with the urgency of the current global crisis.

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