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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (3): 243-246.doi: 10.3736/jcim20070303

• Editorial • Previous Articles     Next Articles

Case recruitment in large-scale clinical trials of traditional Chinese medicine

Hong-bo Cao, Hong-cai Shang, Ming Ren, Jun-hua Zhang, Xin Gao, Yao-zu Xiang, Guo-hua Dai, Yang Wang, Xiu-mei Gao, Bo-li Zhang   

  1. Clinical Research Assessment Centre, Research Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
  • Online:2007-05-31 Published:2007-05-15

Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".

Key words: traditional Chinese medicine, randomized controlled trials, patient participation, patient selection

CLC Number: 

  • R-3
[1] Lovato LC, Hill K, Hertert S , et al. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials, 1997,18(4):328-352
doi: 10.1016/S0197-2456(96)00236-X pmid: 9257072
[2] Ferland D, Fortin PR . Recruitment strategies in superiority trials in SLE:lessons from the study of methotrexate in lupus erythematosus(SMILE). Lupus, 1998,8(8):606-611
[3] McNeely EA, Clements SD . Recruitment and retention of the older adult into research studies. J Neurosurg Nurs, 1994,26(1):57-61
doi: 10.1145/2556288.2557004 pmid: 8195652
[4] Ory MG, Lipman PD, Karlen PL , et al. Recruitment of older participants in frailty/injury prevention studies. Prev Sci, 2002,3(1):1-22
doi: 10.1023/A:1014610325059 pmid: 12002555
[5] Hunninghake DB, Darby CA, Probstfield JL . Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials, 1987,8(4 Suppl):6S-30S
doi: 10.1016/0197-2456(87)90004-3 pmid: 3326716
[6] Shang HC, Zhang JH, Dai GH , et al.Administration and quality control of large-scale clinical trial of traditional Chinese medicine. Zhong Xi Yi Jie He Xue Bao, 2007, 5(1):1-4. Chinese with abstract in English
[7] Chang BH, Hendricks AM, Slawsky MT , et al. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC Med Res Methodol, 2004,4:8
[8] Perquin DA, de Craen AJ, Helmerhorst FM . Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography. Reprod Health, 2006,3:5
doi: 10.1186/1742-4755-3-5 pmid: 16772036
[9] King M, Nazareth I, Lampe F , et al. Impact of participant and physician intervention preferences on randomized trials: systematic review. JAMA, 2005,293(9):1089-1099
[10] Ross S, Grant A, Counsell C , et al. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol, 1999,52(12):1143-1156
doi: 10.1016/S0895-4356(00)00279-1 pmid: 11243239
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