Research progress of clinical endpoints in clinical trials of novel antituberculosis agents

doi:10.3969/j.issn.1000-6621.2021.01.018

Abstract

Abstract:

Bactericidal activity and sterilizing activity should be evaluated in clinical trials of novel antituberculosis agents. Early bactericidal activity and sputum culture conversion used to be main indicators for evaluating clinical responses in phase Ⅱ trials, while cure without relapse were frequently used as endpoint in phase Ⅲ trials. Recent studies showed that sputum culture conversion time, quantification of CT and PET-CT lesions and GeneXpert MTB/RIF threshold cycle could be used as surrogate endpoints of clinical trials.

Key words: Antitubercular agents, Clinical trial,phase Ⅱ, Clinical trial,phase Ⅲ, Drug evaluation,preclinical

DUAN Hong-fei, CHU Nai-hui. Research progress of clinical endpoints in clinical trials of novel antituberculosis agents[J]. Chinese Journal of Antituberculosis, 2021, 43(1): 96-99. doi: 10.3969/j.issn.1000-6621.2021.01.018

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