Prospective Registration of Marker Evaluation Studies: Time to Act

[摘要] In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy requiring investigators to deposit essential information about trial design into an accepted clinical trials registry before the onset of patient enrollment. This policy was aimed at ensuring that information about the existence and design of trials was publicly available from the start, a requirement that would stimulate the dissemination of information among clinicians, researchers, and patients. Registration would also help to assure trial participants that the information that accrues as a result of their altruism becomes part of the public record. In addition, prospective trial registration would facilitate transparency and completeness of the reporting of clinical trials and, ultimately, strengthen the validity and value of the scientific evidence base.ICMJE member journals made prior registration a requirement before starting the peer-review process of a submitted trial report. Because of that policy, which has been adopted by many other journals, trial registration became an immediate and major success, and the number of entries into the registries has grown considerably. The WHO Registry Network currently includes 13 primary registries (as of September 2011), which all meet common criteria for content and quality control, and are operated by nonprofit organizations. The WHO International Clinical Trial Registry Platform Search Portal provides a single point of access to a searchable database containing trial registration data sets of all registries in the WHO Registry Network (http://who.int/ictrp/search/en/). This portal has been developed to make it easier for users of registries to search for ongoing and completed clinical trials. Prospective registration of clinical trials is now seen to increase confidence in the results of randomized controlled trials and in the scientific community that …

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