Registration of a clinical trial requires that researchers document key aspects of
their research methodology in a publically available database. In the words of the
International Committee of Medical Journal Editors, the registration of clinical trials
is needed “to prevent selective publication and selective reporting of research outcomes,
to prevent unnecessary duplication of research efforts, to help patients and the public
know what trials are planned or ongoing into which they might want to enroll, and
to help give ethics review boards considering approval of new studies a view of similar
work and data relevant to the research they are considering.”
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Any journal that wants to follow the International Committee of Medical Journal Editors guidelines
must require registration, and authors who state that they abide by the Declaration
of Helsinki must register their trial before the first patient is enrolled. Trial
registration is also required by regulations of the U.S. Food and Drug Administration,
European Union, and World Health Organization (https://clinicaltrials.gov/ct2/manage-recs/background).International Committee of Medical Journal Editors. Clinical Trial Registration. Available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Accessed October 12, 2015.
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References
International Committee of Medical Journal Editors. Clinical Trial Registration. Available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Accessed October 12, 2015.
- Clinical trial registration in physical therapy journals: recommendations from the International Society of Physiotherapy Journal Editors.Phys Ther. 2013; 93: 6-10
World Health Organization. International Clinical Trials Registry Platform (ICTRP): welcome to the WHO ICTRP. Available at: http://www.who.int/ictrp/en. Accessed October 12, 2015.
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© 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
