目前臨床研究協調員（CRC）在完成高質量的臨床試驗中所扮演的角色越來越受到國內藥物臨床試驗機構及藥物申辦者的廣泛關注。作為臨床試驗過程中重要的一員，CRC承擔著協調及管理臨床試驗項目的任務，具有“項目管理助手、后勤保障支持”的特點。四川大學華西醫院國家藥物臨床試驗機構在中醫專業新藥臨床試驗過程中，嘗試配備CRC并在實際工作中取得了一定成效，同時也積累了實踐經驗。現就該機構中醫專業新藥臨床試驗過程中，CRC的運行機制和具體工作職責進行簡要介紹，為各藥物臨床試驗機構的建設和管理、藥物臨床試驗的質量和整體水平的提高提供參考。
Objective To evaluate the effectiveness and safety of traditional Chinese medicine (TCM) plus transcatheter arterial chemoembolization (TACE) compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma (HCC). Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analyses were performed for homogeneous studies using The Cochrane Collaboration’s RevMan 4.2.10 software. Subgroup analyses by frequency of TACE (lt;3 or ≥3 times) were also performed. Results Thirty seven trials, all published in China, involving 2 653 participants were included. The quality of 2 studies was graded B (medium) and that of the other 35 was graded C (low). Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response (complete and partial), quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC. As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high-quality randomized controlled trials are needed.