Clinical Trial Registration
Clinical trial registration is the prospective documentation of a trial's key information (hypothesis, design, population, outcomes) in a public registry before enrollment begins or results are known. In 2005, the World Health Organization established the requirement that all clinical trials be registered in an internationally recognized registry before participant enrollment. The International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in major medical journals in 2005, updated in 2015. Primary registries include ClinicalTrials.gov (U.S.), ISRCTN (UK), EudraCT (EU), and others operating under WHO oversight. Registration serves to prevent selective outcome reporting, reduce publication bias, and enhance research transparency.
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- World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement. · URL
- International Committee of Medical Journal Editors. (2015). Recommendations for the Conduct, Reporting, Editorship, and Publication of Scholarly Work in Medical Journals. JAMA, 314(20), 2142-2150. · URL
- U.S. Food and Drug Administration. (2020). Expanded Access (Compassionate Use). Electronic Code of Federal Regulations Title 21, Section 312.300. · URL
- De Angelis, C., Drazen, J. M., Frizelle, F. A., Haivas, G., Hebert, P. C., Ioannidis, J. P., & Schroeder, T. V. (2004). Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors. N Engl J Med, 351(12), 1250-1251. · DOI 10.1056/NEJMe048225
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