Traditional Chinese Drug Clinical Trials, Quality Control And Assurance

Some problems are found in quality control and quality assurance in the present clinical trials of TCM new drugs through the monitoring courses of phase II ,111 and IV clinical studies of several new drugs. They are: 1 .The standard operating processes (SOPs) are too sweeping and of less practicability, and TCM symptoms and signs are judged freely, 2. The investigators' compliance in clinical studies is hard to be guaranteed, 3.The patients' compliance in clinical studies is beyond control, 4.The SOPs of phase IV are pending further discussion.Based upon my tutor Prof. Yang Mingjun's experience on many years of the research and development of new drugs, in combination with the analysis on TCM clinical trials in our country, it is believed that: 1. The SOPs, esp. the SOPs in judging TCM symptoms and signs, remain to be perfected in terms of good clinical practice, according to the situation of our country and the specialties of TCM new drugs, 2. As a measure for quality control, the contract research organization (CRO) is advisable to be recommended to perform management, organization and coordination in clinical trials so as to ensure the compliance of investigators, 3. Another measure for quality assurance is a TCM new drug community that is cultivated for ensuring the compliance of patients in clinical trials, 4.The discussion on the specific objectives of phase IV clinical trials shows that the SOP in each phase of the clinical trials has its own characteristics because each phase lays particular emphasis on different objectives.The organized manner of CRO and a tentative mode of TCM new drug community are applied in the phase IV clinical trials of Shengxuening Tablet in treating iron-deficiency anemia ( qi-blood vacuity pattern). It is approved that CRO and TCM new drug community have contributed to the quality control and quality assurance on clinical studies.