Registration and Reporting Guidelines for Clinical Trials / 대한내과학회지

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.

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

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.