WANG Lei1,LIU Jun1,DANG Hai-xia1,WANG Zhong1,REN Jing-tian2,SHEN Chun-ti3*
1.Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences,Beijing 100700, China;
2.Center for Drug Reevaluation of China Food and Drug Administration, Beijing 100045, China;
3.Changzhou TCM Hospital Attached Nanjing University of Traditional Chinese Medicine,Changzhou 213003, China
Abstract��
OBJECTIVE The purpose of this paper is to introduce the establishment and operation of Clinical Trial Data and Safety Monitoring Board (DSMB). METHODS Based on the platform of Phase �� clinical trials for Danhong Injection, and the FDA guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees”, we made the rule and standard operating procedure of DSMB for Danghong Injection Phase �� clinical trials according to the purposes, study designs of the trials and the responsibilities of DSMB. RESULTS Independent DSMB has been established in the trials of Danhong injection. The members in DSMB included clinicians, statisticians and bioethicists. DSMB established the standard operating procedure, responsibilities and committee rules. DSMB mostly held different forms of meeting to perform its responsibilities. It evaluated the operation of the trials mostly through two ways: EDC system centralized monitoring and on-site inspection. It also formulated and carried out the interim analysis in certain times to revaluate the sample size, to improve the success rate of the trials. All above operations could better protect the safety and interests of the participants, ensure the authenticity and reliability of the clinical trial data and further improve the controllability on the quality of clinical trials. CONCLUSION DSMB could not only protect the safety and interests of the participants, but also ensure the scientificity of study outcomes. The establishment and operation of DSMB in Danhong Injection Phase �� trials takes a good example for other studies.
WANG Lei-,
LIU Jun-,
DANG Hai-Xia- etc
.Data and Safety Monitoring of Danhong Injection in �� Clinical Trials[J] Chinese Pharmaceutical Journal, 2015,V50(4): 375-378
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