国际临床试验注册概述

doi:10.3736/jcim20070302

Abstract

Clinical trials play a critical role in medical research. However, only a few clinical trials conducted at present have been registered at various clinical trial registries. Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats. Moreover, it will benefit the development of evidence-based medicine, and promote human welfare. Great attention has been paid to the importance and necessity of clinical trial registration. This review briefly introduced the definition, justification, contents, history, current status of clinical trial registration, and introduced the information regarding important international clinical trial registries in detail. Clinical trial registration should be developed toward a transparent, compulsory and comprehensive stage.

Key words: clinical trials, international agencies, evidence-based medicine

CLC Number:

R-20

He Yu, Jian-ping Liu. A review of international clinical trial registration. Journal of Chinese Integrative Medicine, 2007, 5(3): 234-242.

/ / Recommend

Add to citation manager EndNote| Reference Manager|ProCite|BibTeX|RefWorks

URL: http://www.jcimjournal.com/EN/10.3736/jcim20070302

http://www.jcimjournal.com/EN/Y2007/V5/I3/234

TrendMD

References 41

[1]	Tonks A . Registering clinical trials. BMJ, 1999,319(7224):1565-1568
[2]	.[ OTHER]. WHO. The world health organization announces new standards for registration of all human medical research. [2006-12-04]. THER].WHO. The world health organization announces new standards for registration of all human medical research.[ 2006-12-04]. .WHO. The world health organization announces new standards for registration of all human medical research. [2006-12-04]. THER].WHO. The world health organization announces new standards for registration of all human medical research. [2006-12-04]. .
[3]	Horton R, Smith R . Time to register randomised trials. The case is now unanswerable. BMJ, 1999,319(7214):865-866
[4]	.[ OTHER]. Pawar S. The new clinical trials registry: An overview. [2006-12-04]. THER].Pawar S. The new clinical trials registry: An overview.[ 2006-12-04]. .Pawar S. The new clinical trials registry: An overview. [2006-12-04]. THER].Pawar S. The new clinical trials registry: An overview. [2006-12-04]. .
[5]	Steinbrook R . Registration of clinical trials--voluntary or mandatory?. N Engl J Med, 2004,351(18):1820-1822 doi: 10.1056/NEJMp048264 pmid: 15509812
[6]	De Angelis CD, Drazen JM, Frizelle FA , et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Haematologica, 2006,91(3):293-295
[7]	Moher D . Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Haematologica, 2006,91(3):293-295
[8]	刘建平, 张晶, 陈均超 . 人体医疗类干预临床试验研究方案信息与结果的国际注册原则——渥太华声明(第Ⅰ部分). 循证医学, 2006,6(2):109-112
	Liu JP, Zhang J, Chen JC . Principles for international registration of protocol information and results from human trials of health-related interventions: Ottawa statement(Part 1). Xun Zheng Yi Xue, 2006,6(2):109-112
[9]	Steinbrook R . Public registration of clinical trials. N Engl J Med, 2004,351(4):315-317 doi: 10.1227/01.neu.0000309521.28309.3b pmid: 15269307
[10]	Reynolds T . Researchers push for publication, registration of all clinical trials. J Natl Cancer Inst, 2003,95(11):772-774 doi: 10.1093/jnci/95.11.772 pmid: 12783924
[11]	Wille-Jorgensen P, Gluud C . Prospective registration of clinical trials. Colorectal Dis, 2006,8(1):1 doi: 10.1016/S0004-9514(06)70002-2 pmid: 17132117
[12]	Abbasi K . Compulsory registration of clinical trials. BMJ, 2004,329(7467):637-638 doi: 10.1136/bmj.329.7473.1044 pmid: 524569
[13]	.[ OTHER]. 5月20日: 关注国际临床试验日.中国医学论坛报. [2006-12-04]. THER].5月20日: 关注国际临床试验日.中国医学论坛报.[ 2006-12-04]. .5月20日: 关注国际临床试验日.中国医学论坛报. [2006-12-04]. THER].5月20日: 关注国际临床试验日.中国医学论坛报. [2006-12-04]. .
	[ OTHER]. May 20th: pay close attention to the international clinical trial's day. Zhongguo Yi Xue Lun Tan Bao. [2006-12-04]. THER].May 20th: pay close attention to the international clinical trial's day. Zhongguo Yi Xue Lun Tan Bao.[ 2006-12-04]. .May 20th: pay close attention to the international clinical trial's day. Zhongguo Yi Xue Lun Tan Bao. [2006-12-04]. THER].May 20th: pay close attention to the international clinical trial's day. Zhongguo Yi Xue Lun Tan Bao. [2006-12-04]. .
[14]	Watson R . WHO calls for registration of all clinical trials. BMJ, 2006,332(7552):1232 doi: 10.1136/bmj.332.7552.1232-c pmid: 16735316
[15]	.[ OTHER]. 中国临床试验注册中心首页. [2007-03-02]. THER].中国临床试验注册中心首页.[ 2007-03-02]. .中国临床试验注册中心首页. [2007-03-02]. THER].中国临床试验注册中心首页. [2007-03-02]. .
	[ OTHER]. The homepage of Chinse clinical trial register. [2007-03-02]. THER].The homepage of Chinse clinical trial register.[ 2007-03-02]. .The homepage of Chinse clinical trial register. [2007-03-02]. THER].The homepage of Chinse clinical trial register. [2007-03-02]. .
[16]	.[ OTHER]. WHO. International clinical trials registry platform. [2006-12-04]. THER].WHO. International clinical trials registry platform.[ 2006-12-04]. .WHO. International clinical trials registry platform. [2006-12-04]. THER].WHO. International clinical trials registry platform. [2006-12-04].
[17]	.[ OTHER]. Department of Health Research and Development. The national research register: what is the national research register. [2006-12-04]. THER].Department of Health Research and Development. The national research register: what is the national research register.[ 2006-12-04]. .Department of Health Research and Development. The national research register: what is the national research register. [2006-12-04]. THER].Department of Health Research and Development. The national research register: what is the national research register. [2006-12-04].
[18]	Van Der Weyden MB, Ghersi D . The Australian clinical trial registry. Med J Aust, 2005,183(1):7 doi: 10.1503/cmaj.1040841 pmid: 15992328
[19]	Haug C, Gotzsche PC, Schroeder TV . Registries and registration of clinical trials. N Engl J Med, 2005,353(26):2811-2812 doi: 10.1056/NEJMe058280 pmid: 16382070
[20]	Krleza-Jeric K . Clinical trial registration: the differing views of industry, the WHO, and the Ottawa group. Plos Med, 2005,2(11):e378 doi: 10.1371/journal.pmed.0020378 pmid: 1255765
[21]	.[ OTHER]. GlaxoSmithKline clinical trial register. Welcome to the GlaxoSmithKline clinical trial register. [2006-12-04]. THER].GlaxoSmithKline clinical trial register. Welcome to the GlaxoSmithKline clinical trial register.[ 2006-12-04]. .GlaxoSmithKline clinical trial register. Welcome to the GlaxoSmithKline clinical trial register. [2006-12-04]. THER].GlaxoSmithKline clinical trial register. Welcome to the GlaxoSmithKline clinical trial register. [2006-12-04]. .
[22]	Krall R, Rockhold F . More on compulsory registration of clinical trials: GSK has created useful register. BMJ, 2005,7489(11):479-480 doi: 10.1136/bmj.330.7489.479-b pmid: 549698
[23]	.[ OTHER]. Trials Central. Trials Central: Your source for online clinical trials information. [2006-12-04]. THER].Trials Central. Trials Central: Your source for online clinical trials information.[ 2006-12-04]. .Trials Central. Trials Central: Your source for online clinical trials information. [2006-12-04]. THER].Trials Central. Trials Central: Your source for online clinical trials information. [2006-12-04].
[24]	Batmanabane G . ICMJE statement on compulsory clinical trial registration: should Indian journals follow suit?. Indian J Med Ethics, 2005,2(3):74-75 doi: 10.4103/0253-7613.16565 pmid: 16276635
[25]	Bonati M, Pandolfini C . Trial registration, the International Committee of Medical Journal Editors statement and pediatric journals. Paediatr Anaesth, 2006,16(1):92
[26]	Zarin DA, Tse T, Ide NC . Trial registration at clinical trials.gov between May and October 2005. N Engl J Med, 2005,353(26):2779-2787
[27]	Couser WG, Drueke T, Halloran P , et al. Uniform clinical trial registration policy for journals of kidney diseases, dialysis, and transplantation. J Am Soc Nephrol, 2005,16(4):837
[28]	.[ OTHER]. The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04]. THER].The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials.[ 2006-12-04]. .The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04]. THER].The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04].
	[ OTHER]. The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04]. THER].The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials.[ 2006-12-04]. .The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04]. THER].The Cochrane Library. Product descriptions: Cochrane Central Register of Controlled Trials. [2006-12-04]. .
[29]	Zielinski SL . Clinical trials registration efforts gain some ground. J Natl Cancer Inst, 2005,97(6):410-411 doi: 10.1093/jnci/97.6.410 pmid: 15769999
[30]	Sataloff RT . Clinical trials: The case for registration. Ear Nose Throat J, 2006,85(6):352-353 pmid: 16866101
[31]	.[ OTHER]. European Cancer Patient Coalition. Open comments of cancer patients to who on delayed public disclosure of clinical trials information. [2006-12-04]. THER].European Cancer Patient Coalition. Open comments of cancer patients to who on delayed public disclosure of clinical trials information.[ 2006-12-04]. .European Cancer Patient Coalition. Open comments of cancer patients to who on delayed public disclosure of clinical trials information. [2006-12-04]. THER].European Cancer Patient Coalition. Open comments of cancer patients to who on delayed public disclosure of clinical trials information. [2006-12-04].
[32]	Braillon A, Dubois G, Slama M . Registration of clinical Trials. Ann Intern Med, 2005,142(3):228
[33]	Gulmezoglu AM, Sim I . International clinical trial registration: any progress?. Wien Klin Wochenschr, 2006,118(1-2):1-2 doi: 10.1007/s00508-006-0525-1 pmid: 16489516
[34]	Sim I, Chan AW, Gulmezoglu AM , et al. Clinical trial registration: transparency is the watchword. Lancet, 2006,367(9523):1631-1633 doi: 10.1016/S0140-6736(06)68708-4 pmid: 16714166
[35]	Fleck F . No delayed disclosure for registration of clinical trials. Bull World Health Organ, 2006,84(6):430 doi: 10.1590/S0042-96862006000600006
[36]	Stewart L, Vale C, Darbyshire J . Compulsory registration of clinical trials: publicly funded national register of trials would be best in the United Kingdom. BMJ, 2004,329(7473):1043-1044
[37]	Humphreys G . Giving patients better access to trial information. Bull World Health Organ, 2006,84(6):429-431 doi: 10.1590/S0042-96862006000600005
[38]	Jay P, Wallace M . Compulsory registration of clinical trials under-reporting is not an option. BMJ, 2004,329(7473):1044 doi: 10.1136/bmj.329.7473.1044-a pmid: 15514361
[39]	Abbasi K, Godlee F . Next steps in trial registration minimum criteria have been agreed, and intentions restated. BMJ, 2005,330(7502):1222-1223 doi: 10.1136/bmj.330.7502.1222 pmid: 558081
[40]	De Angelis CD, Drazen JM, Frizelle FA , et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Arch Otolaryngol Head Neck Surg, 2005,131(6):479-480
[41]	Rennie D . Trial registration: a great idea switches from ignored to irresistible. JAMA, 2004,292(11):1359-1362

Related Articles 15

[1]	Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[2]	Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[3]	Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[4]	Arthur de Sá Ferreira, Antonio Guilherme Pacheco. SimTCM: A human patient simulator with application to diagnostic accuracy studies of Chinese medicine. Journal of Integrative Medicine, 2015, 13(1): 9-19.
[5]	Subhranil Saha, Munmun Koley, Subhasish Ganguly, Prasanta Rath, Pulak Roy Chowdhury, Seikh Intaj Hossain. Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study. Journal of Integrative Medicine, 2014, 12(1): 13-19.
[6]	Christoph A. Doenitz, Ana Anjos, Thomas Efferth , Tobias Greten, Henry J. Greten. Can heat and cold be parameterized? Clinical data of a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(5): 532-537.
[7]	Dong-tao Li, Jian Wang , Hong-yang Jiang , Feng-lei Shi , Fu-yu Li , Ji-hong Liu , Yong-mei Cheng , Nan Yan , Ai-hua Hu, Mei-zeng Zhang , Jie Li, Ling-bo Wei , Rong-qin Jiang. Quantitative evaluation of the degrees of traditional Chinese medicine qualitative syndromes of osteoporosis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1254-1262.
[8]	Ping Wang , Xu-dong Tang , Bao-yan Liu , Ming-jie Zi . Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: Item selection. Journal of Chinese Integrative Medicine, 2012, 10(10): 1092-1098.
[9]	Yu Huang, Xing Zeng, Wei Zhu, Sha-sha Li, Dan Zhou, Chuan-jian Lu. Correlation between T lymphocyte subsets and different syndrome types in patients with influenza A (H1N1): A retrospective study. Journal of Chinese Integrative Medicine, 2011, 9(2): 143-147.
[10]	Wan-li Gu , Zai-xiang Shi, Yun-xu Yu, Yu-wei Wu, Bao-wei Lu, Ka-kit Hui . Distribution characteristics of syndrome types in essential hypertension. Journal of Chinese Integrative Medicine, 2010, 8(9): 842-847.
[11]	Si-cheng Wang, Jian-ping Liu, Hui Li, He Yu. Guidelines for evidence-based Chinese medicine clinical pathway report. Journal of Chinese Integrative Medicine, 2010, 8(9): 819-823.
[12]	Hugh MacPherson , Douglas G Altman , Richard Hammerschlag , Youping Li , Taixiang Wu , Adrian White, David Moher . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(9): 804-818.
[13]	MacPherson H. Towards better reporting of interventions in clinical trials of acupuncture. Journal of Chinese Integrative Medicine, 2010, 8(9): 801-803.
[14]	David Moher, Sally Hopewell, Kenneth F Schulz, Victor Montori, Peter C Gtzsche, P J Devereaux, Diana Elbourne, Matthias Egger, Douglas G Altman. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(8): 701-741.
[15]	Kenneth F Schulz, Douglas G Altman, David Moher, the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(7): 604-612.

Metrics

Viewed

Full text

Abstract

Cited

Shared

Discussed

Comments

Recommended 10

[1]	Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[2]	Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3]	Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4]	Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[5]	A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H₂₂ cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[6]	Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7]	Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[8]	Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9]	Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[10]	Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022

A review of international clinical trial registration

RichHTML

PDF (PC)

Like