Risk assessment and control for clinical trial of new tuberculosis intradermal diagnostic reagents

Abstract

Abstract: In order to reduce the risk of clinical trial for new tuberculosis intradermal diagnostic reagents in China, we made the risk assessment and provided the corresponding prevention and control measures for their clinical trial under the normal usage of qualified products. During the risk assessment, we took the Chinese laws and regulations on clinical trials as the guideline and referring to the evaluation of reported adverse events of OT and TB/BCG PPD close to such products in function and applicable people.

Key words: Tuberculosis/diagnosis, Intradermal tests, Indicators and reagents, Risk assessment

XU Miao, PU Jiang, YANG Lei, LU Jin-biao, TAO Li-feng, ZHONG Zai-xin, CHEN Bao-wen, DU Wei-xin, WANG Guo-zhi. Risk assessment and control for clinical trial of new tuberculosis intradermal diagnostic reagents[J]. Chinese Journal of Antituberculosis, 2013, 35(6): 460-462.

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