J Korean Med Assoc.  2011 Jan;54(1):92-97.

Primary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS)

Affiliations
  • 1Division of Cadiovascular and Rare Disease, National Institute of Health, Korea Centers for Disease Control and Prevention, Cheongwon, Korea. hypark65@nih.go.kr

Abstract

Publication bias has a negative impact on the ability of healthcare providers and consumers to make unbiased healthcare decisions. The demand for greater transparency of clinical trials has increased and a prospective registry has been suggested by the International Committee of Medical Journal Editors. By 2008, prospective registration was considered as an ethical requirement within the Declaration of Helsinki. In Korea, the clinical research registry named 'Clinical Research Information Service (CRIS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. This means that CRIS conforms to the WHO registry criteria and that registering trials with the CRIS satisfies the trial registration policies of many medical journals. To improve the comprehensiveness and completeness of registered clinical research data, it is necessary to communicate and raise awareness of the need to register clinical trials, as well as to establish national policies on clinical trial registration.

Keyword

Clinical trial registration; Publication bias; Ethics; Clinical Research Information Service; World Health Organization International Clinical Trial Registry Platform

MeSH Terms

Delivery of Health Care
Health Personnel
Helsinki Declaration
Humans
Information Services
Korea
Publication Bias
World Health Organization

Reference

1. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986. 4:1529–1541.
Article
2. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA. 1990. 263:1385–1389.
Article
3. Dickersin K, Min YI. Publication bias: the problem that won't go away. Ann N Y Acad Sci. 1993. 703:135–146.
Article
4. FDAMA section 113: status report on implementation [Internet]. 2005. cited 2010 Dec 15. Silver Spring: Food and Drug Administration;Available from: http://www.fda.gov/downloads/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/UCM148894.pdf.
5. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Internet]. 2004. cited 2010 Dec 15. International Committee of Medical Journal Editors;Available from: http://www.icmje.org/clin_trial.pdf.
6. Clinical trial registration: looking back and moving ahead [Internet]. 2007. cited 2010 Dec 15. International Committee of Medical Journal Editors;Available from: http://www.icmje.org/update_june07.html.
7. Public law 110-85. Food and Drug Administration Amendments Act (FDAAA) of 2007 [Internet]. 2007. cited 2010 Dec 15. Silver Spring: Food and Drug Administration;Available from: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdfhttp://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf.
8. WMA Declaration of Helsinki: ethical principles for medical research involving human subjects [Internet]. 2008. cited 2010 Dec 15. Ferney-Voltaire: World Medical Association, Inc.;Available from: http://www.wma.net/en/30publications/10policies/b3/index.html.
9. International Clinical Trials Registry Platform [Internet]. 2008. cited 2010 Dec 15. Geneva: World Health Organization;Available from: http://www.who.int/ictrp/about/details/en/index.html.
10. International Clinical Trials Registry Platform: WHO Data Set [Internet]. 2008. cited 2010 Dec 31. Geneva: World Health Organization;Available from: http://www.who.int/ictrp/network/trds/en/index.html.
Full Text Links
  • JKMA
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2023 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr