임상시험 등록시스템 및 연구결과 보고지침
Registration and Reporting Guidelines for Clinical Trials
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초록
임상연구는 사람을 대상으로 하기 때문에 그 내용 및 과정에 있어서 엄격한 윤리성과 과학적 객관성이 요구된다. 연구 시작 전부터 임상시험등록을 하고, 절차를 투명하게 공개하며, 연구 결과를 표준화된 지침에 맞춰 보고하는 체계는 이제는 거스를 수 없는 흐름이 되었다. 힘겨운 작업이기 보다는 좀 더 양질의 연구를 수행하고, 검증된 연구 보고들를 보다 쉽게 선택할 수 있는 기회가 많아졌다는 생각이 더 옳을 것이다. 나아가 이러한 흐름은 의학적 진료지침(guideline) 마련 등의 중대한 의학적 의사결정에 큰 도움이 되리라 예상한다. 아울러, 국내 임상시험등록관리시스템의 구축으로 인해 국내 임상연구 수행의 정보를 국제적으로 공유함으로써, 국내 연구의 객관성 향상과 윤리적 수행뿐 아니라, 연구 수준의 우수함을 해외에 홍보하는 기회가 될 것으로 생각된다. 이러한 등록관리시스템의 성공적 운영을 위해서는 정부의 지원 뿐 아니라 민간차원, 특히 연구수행자들의 적극적 참여가 필요할 것이다.
Abstract
Selective outcome reporting is a major problem because it has a negative impact on our scientific knowledge and is unethical as it involves research on human subjects. And inadequate quality of trials may distort the results from systematic reviews and meta-analyses. Thus, Clinical medicine tries to solve the problem of trials by making public registration before patient enrollment mandatory and encouraging to report the research outcomes by a specific guidelines. In the past few years, the registration of clinical trials and the reporting system has become routine, supported by the International Committee of Medical Journal Editors. 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. To expand the registration system and to operate them successfully and comprehensively, active participations of researchers as well as the government supports are required. (Korean J Med 2012;83:309-318)
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