BMJ  2005;330:956-958 (23 April), doi:10.1136/bmj.330.7497.956

Education and debate

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

¹ Randomised Controlled Trials Unit, Canadian Institutes of Health Research, Ottawa, 160 Elgin Street, Ottawa ON, K1A 0W9, Canada, ² Department of Community Health, Brown University, Providence, USA, ³ Department of Medicine, University of California, San Francisco, USA, ⁴ Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada, ⁵ European Clinical Research Infrastructures Network, Copenhagen University Hospital, Copenhagen, Denmark

Registering of trials is essential to make sure all results are publicly available and that ethical obligations to participants are met

The first 150 words of the full text of this article appear below.

Introduction

Recent evidence of selective reporting of results has eroded public and academic confidence in publications of clinical trials, leading to renewed calls for trial registration.^1-5 The dangers of non-disclosure of trial results, although described for years, sparked an international furore last spring after the publication of two systematic reviews on the effects of selective serotonin reuptake inhibitors for childhood depression.^{1 6} Subsequent legal proceedings⁷ and policy statements by journal editors,^{8 9} medical associations,¹⁰ and industry¹¹ have recognised the importance of trial registration. The rationale for registering trials is well known (box 1).^{12 13} Most importantly, the contribution to social good that justifies research on human participants is not realised when resulting knowledge remains invisible.

As an interested and neutral party that has been registering the trials that it funds,¹⁴ the Canadian Institutes of Health Research hosted an open meeting on 4 October 2004 in Ottawa, Canada, to foster international consensus on trial registration. . . . [Full text of this article]

Summary of principles

Key principles

Registering all types of trials
Timing of public release of protocol information
Registering unpublished results

Next steps

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

How should we rate research?: Cost of research should be disclosed publicly

Ludovic Reveiz
BMJ 2006 332: 1215. [Extract] [Full Text]

Waiving confidentiality for the greater good

An-Wen Chan, Ross Upshur, Jerome A Singh, Davina Ghersi, François Chapuis, and Douglas G Altman
BMJ 2006 332: 1086-1089. [Full Text] [PDF]

Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution

Nandi Siegfried, Mike Clarke, and Jimmy Volmink
BMJ 2005 331: 742. [Abstract] [Full Text] [PDF]

Next steps in trial registration

Kamran Abbasi and Fiona Godlee
BMJ 2005 330: 1222-1223. [Extract] [Full Text] [PDF]

Why industry should register and disclose results of clinical studies—perspective of a recovering academic

Jesse A Berlin
BMJ 2005 330: 959. [Extract] [Full Text] [PDF]

Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors

An-Wen Chan and Douglas G Altman
BMJ 2005 330: 753. [Abstract] [Full Text] [PDF]

Compulsory registration of clinical trials

Kamran Abbasi
BMJ 2004 329: 637-638. [Extract] [Full Text] [PDF]

GlaxoSmithKline faces US lawsuit over concealment of trial results

Owen Dyer
BMJ 2004 328: 1395. [Extract] [Full Text] [PDF]

Efficacy and safety of antidepressants for children and adolescents

Jon N Jureidini, Christopher J Doecke, Peter R Mansfield, Michelle M Haby, David B Menkes, and Anne L Tonkin
BMJ 2004 328: 879-883. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• Zarin, D. A., Ide, N. C., Tse, T., Harlan, W. R., West, J. C., Lindberg, D. A. B. (2007). Issues in the Registration of Clinical Trials. JAMA 297: 2112-2120 [Abstract] [Full text]  
• Coultas, D. (2007). Ethical Considerations in the Interpretation and Communication of Clinical Trial Results. Proc Am Thorac Soc 4: 194-199 [Abstract] [Full text]  
• Zarin, D. A., Keselman, A. (2007). Registering a Clinical Trial in ClinicalTrials.gov. Chest 131: 909-912 [Full text]  
• Shearer, M. J., Torgerson, D. J., Cockayne, S., Adamson, J., Lanham-New, S., Gilbody, S. (2007). Vitamin K and the Prevention of Fractures--Reply. Arch Intern Med 167: 94-95 [Full text]  
• Kelland, N F, Webb, D J (2007). Clinical trials of endothelin antagonists in heart failure: publication is good for the public health. Heart 93: 2-4 [Abstract] [Full text]  
• Santoro, E., Rossi, V., Pandolfini, C., Bonati, M. (2006). DEC-net: the development of the European register of clinical trials on medicines for children. Clin Trials 3: 366-375 [Abstract]  
• Reveiz, L. (2006). How should we rate research?: Cost of research should be disclosed publicly.. BMJ 332: 1215-1215 [Full text]  
• Chan, A.-W., Upshur, R., Singh, J. A, Ghersi, D., Chapuis, F., Altman, D. G (2006). Waiving confidentiality for the greater good.. BMJ 332: 1086-1089 [Full text]  
• Gotzsche, P. C., Hrobjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., Chan, A.-W. (2006). Constraints on Publication Rights in Industry-Initiated Clinical Trials. JAMA 295: 1645-1646 [Full text]  
• Goodyear, M. (2006). Learning from the TGN1412 trial. BMJ 332: 677-678 [Full text]  
• Haug, C., Gotzsche, P. C., Schroeder, T. V. (2005). Registries and Registration of Clinical Trials. NEJM 353: 2811-2812 [Full text]  
• Laforest, C., Selva, D., Crompton, J., Leibovitch, I. (2005). Entopic Phenomenon as Initial Presentation of Acute Myelogenous Leukemia. ANN INTERN MED 143: 847-848 [Full text]  
• Gluud, C (2005). Mortality from cirrhosis: lack of progress over the last 35 years. Gut 54: 1523-1526 [Full text]  
• Williamson, P R, Gamble, C, Altman, D G, Hutton, J L (2005). Outcome selection bias in meta-analysis. Stat Methods Med Res 14: 515-524 [Abstract]  
• Siegfried, N., Clarke, M., Volmink, J. (2005). Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution. BMJ 331: 742- [Abstract] [Full text]  
• Chapman, S (2005). Research from tobacco industry affiliated authors: need for particular vigilance. Tobacco Control 14: 217-219 [Full text]  
• Abbasi, K., Godlee, F. (2005). Next steps in trial registration. BMJ 330: 1222-1223 [Full text]  
• Berlin, J. A (2005). Why industry should register and disclose results of clinical studies--perspective of a recovering academic. BMJ 330: 959-959 [Full text]  

Rapid Responses:

Read all Rapid Responses

Wrong web address and wrong date

Karmela Krleza-Jeric
bmj.com, 23 Apr 2005 [Full text]

Trial Registration: Putting Principles into Practice

Ronald L Krall, et al.
bmj.com, 18 May 2005 [Full text]