RESUMEN
It is a moral responsibility of those performing clinical studies towards patients, funding organizations, the scientific community and towards the general public to publish the results of clinical trials. Under-reporting of clinical trials with null or even negative results as well as over-reporting of trials with positive results can lead to a biased assessment of (new) treatments, which leads to overestimation of potential benefits and underestimation of potential risks. Comprehensive, publicly accessible clinical trial registries are now widely accepted as an essential tool to fill the information gap. Here, the background for implementing a clinical trials register in Germany is described, whereby publication bias, in particular, is addressed.
Asunto(s)
Ensayos Clínicos como Asunto/legislación & jurisprudencia , Edición/legislación & jurisprudencia , Sistema de Registros , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/estadística & datos numéricos , Difusión de Innovaciones , Ética en Investigación , Medicina Basada en la Evidencia/ética , Medicina Basada en la Evidencia/legislación & jurisprudencia , Alemania , Humanos , Sesgo de Publicación/legislación & jurisprudencia , Sesgo de Publicación/estadística & datos numéricos , Edición/ética , Sistema de Registros/ética , Sistema de Registros/estadística & datos numéricosRESUMEN
In order to provide a central portal for information on clinical research in Germany and thus to facilitate the search of planned, ongoing and completed clinical trials, the German Clinical Trials Register (GermanCTR) was implemented in cooperation with the WHO's registries network. It is an open access online register of clinical trials conducted in Germany, which allows all users to search for, register and share information on clinical trials. The project is funded by the Federal Ministry of Education and Research and is implemented at the Institute for Medical Biometry and Medical Informatics of the University Medical Center Freiburg as a joint project of the Clinical Trials Center Freiburg and the German Cochrane Center. Since October 2008 the GermanCTR is an approved WHO Primary Registry and allows clinical trial registration in Germany according to the requirements of the International Committee of Medical Journal Editors (ICMJE). Reasons for a national trials register, general and technical aspects of implementing the GermanCTR as well as the national and international integration are described here.
