Hanna Hasselblatt1, Gabriele Dreier, Gerd Antes, Martin Schumacher. 1. German Clinical Trials Register, Institute for Medical Biometry and Medical Informatics, University Medical Center Freiburg, Freiburg, Germany. hasselblatt@imbi.uni-freiburg.de
Abstract
OBJECTIVE: It is a moral responsibility towards patients, funding organizations, the scientific community and the general public to publish not only the results of clinical trials but also to inform prospectively about planned trials. This is especially important for scientists, funding organizations, and ethics committees, since they are involved in the planning of new trials, which should rely on the knowledge of existing trials. Moreover, patients can only participate in clinical trials if they or their physicians are aware of ongoing trials for which they are eligible. In order to provide a central portal for information on clinical research in Germany and to facilitate the search for specific trials, the German Clinical Trials Register was implemented in 2008. METHOD: An internet-based prototype of the German Clinical Trials Register was developed in close co-operation with the World Health Organization's registries network on the basis of the internationally harmonized data specification. This was further adapted to a bilingual registry's needs. Co-operation with medical ethics committees in Germany has been initiated with the aim of a joint synergistic data acquisition procedure. RESULTS: The German Clinical Trials Register was launched in August 2008. It was approved as the World Health Organization's primary registry for Germany in October 2008, and fulfils the requirements of the International Committee of Journal Editors. CONCLUSION: The German Clinical Trials Register provides a central bilingual portal for all users (including scientists, patients, physicians, funding organizations, and ethics committees) for information on planned, ongoing, and completed clinical trials conducted in Germany. The German Clinical Trials Register allows International Committee of Journal Editors and World Health Organization-compliant registration of clinical trials in Germany.
OBJECTIVE: It is a moral responsibility towards patients, funding organizations, the scientific community and the general public to publish not only the results of clinical trials but also to inform prospectively about planned trials. This is especially important for scientists, funding organizations, and ethics committees, since they are involved in the planning of new trials, which should rely on the knowledge of existing trials. Moreover, patients can only participate in clinical trials if they or their physicians are aware of ongoing trials for which they are eligible. In order to provide a central portal for information on clinical research in Germany and to facilitate the search for specific trials, the German Clinical Trials Register was implemented in 2008. METHOD: An internet-based prototype of the German Clinical Trials Register was developed in close co-operation with the World Health Organization's registries network on the basis of the internationally harmonized data specification. This was further adapted to a bilingual registry's needs. Co-operation with medical ethics committees in Germany has been initiated with the aim of a joint synergistic data acquisition procedure. RESULTS: The German Clinical Trials Register was launched in August 2008. It was approved as the World Health Organization's primary registry for Germany in October 2008, and fulfils the requirements of the International Committee of Journal Editors. CONCLUSION: The German Clinical Trials Register provides a central bilingual portal for all users (including scientists, patients, physicians, funding organizations, and ethics committees) for information on planned, ongoing, and completed clinical trials conducted in Germany. The German Clinical Trials Register allows International Committee of Journal Editors and World Health Organization-compliant registration of clinical trials in Germany.