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KMID : 0391020060140010017
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2006 Volume.14 No. 1 p.17 ~ p.22
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Clinical Trials Registry
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Choe Seon-Choon
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Abstract
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Clinical trials are more common worldwide, but there are some concerns on the protection of the public and disclosure of all information about investigational products including pharmaceuticals, biologic agents and even medical devices. In order to disclose all kinds of information about clinical trials, clinical trial registration was developed according to the decision by United States Food and Drug Administration (US FDA) and World Health Organization (WHO) separately. From July 1st in 2005, phase II to IV trials which are ’clinically directive’ should be registered in the registries that are 1) easily accessible to the public, 2) free of charge, 3) open to all registrants and not for profits, 4) electronically searchable and 5) capable of ensuring validity of the registration data. This kind of registries are strongly supported by International Committee of Medical Journal Editors (ICMJE). The committee announced that they will consider a trial for publication only if it has been registered before the enrollment of the first patient. So, many multinational pharmaceutical companies have already implemented the registration and even investigators are requested to register the investigator sponsored trials in the clinical trials registry such as ClinicalTrials.gov. In this article, I will explain history, requirement and actual method of registration in clinical trials registry for better understanding and implementation of clinical trials in Korea.
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KEYWORD
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Clinical trial, Clinical trials registry, Clinically directive
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