The DRKS meets the requirements of the ICMJE
The DRKS is the approved WHO Primary Register in Germany and thus meets the requirements of the International Committee of Medical Journal Editors (ICMJE). This committee which is a union of the publishers of the leading international medical journals (amongst others The Lancet, JAMA, NEJM) demands the prospective registration of clinical trials as requirement for any publication (recommendations). Numerous further medical journals support this call.
List of journals
The DRKS in the WHO network
The DRKS is designed in close collaboration with the WHO. The WHO brings together the worldwide activities for the registration of clinical trials on the International Clinical Trials Registry Platform (ICTRP). Its purpose is to allow exchange and to link and develop trial registers worldwide. That means e.g. standardisation of processes to get harmonised data collection and ensure consistent data quality. As a Primary Register, the DRKS is a member of the ICTRP network.
Global search for clinical trials
In order to enable a global search for clinical trials the WHO started a Meta register in May 2007 in which all registers involved bring their data together. A list of the involved registers can be found on the WHO website.
Primary Registry: requirements
The consultation and coordination process of the last years lead to a development and arrangement of the minimal dataset of twenty parameters. Clinical trial registers have next to other requirements to collect at least the data of these parameters and submit it to the WHO in the English language to become an approved Primary Registry of the WHO. For independency and transparency reasons, Primary Registries have to be lead by an independent institution or organization. They have to be free and publicly accessible and have to have a governmental endorsement. Hereby, the WHO wants to ensure that only one registry of each country is allowed to submit data to the WHO portal and furthermore demands national legitimating and support for the trial registry. The DRKS in Germany meets all these requirements and therefore became approved Primary Registry in October 2008.
Cooperation with Ethics Committees
Background: Trial registration is an ethical responsibility
The World Medical Association states in the Declaration of Helsinki, which is a set of ethical principles accepted as a guideline for clinical research worldwide, in paragraph 35:
"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject."
The WHO states on its website:
"The registration of all interventional trials is a scientific, ethical and moral responsibility."
Clinical research has to meet the highest ethical principles.
People participate in clinical trials not only to profit of innovative therapies but also by the conviction to support medical progress with their participation and thus help future patients with the newly won knowledge.
Therefore, it is not just a scientific but also an ethical necessity to make the results of all clinical trials accessible immediately and in an undistorted way (usually as a scientific publication in a journal). However, according to observation in several countries only about 50 % of the once started trials are in the end published.
Trial registries which are publicly accessible aim to correct these deficiencies. With the help of the DRKS and other trials registers, a public birth certificate is created for every trial which makes future "disappearance" impossible and thus provides the possibility to search for results even if there was no journal publication. This is a first step to secure complete accessibility of all trial results.
Cooperation with Medical Ethics Committees in Germany
The necessity of a trial registry from the point of view of an ethics committee was pointed out in 2004 by Victor in "Deutsches Ärzteblatt". Ethics committees assess the risk-benefit ratio for individual participants and the significance of the research project for medical advancement. Furthermore, they assure that patients are adequately informed. The basis for this is knowledge on all finished and ongoing clinical trials as well as the available evidence related to the issue at hand. Because many clinical trials are not published immediately or are not published at all, comprehensive trial registries are necessary to facilitate a meta-analysis before the beginning of each trial. This is the only way to ensure that intended projects are put into perspective to the existing evidence, redundant studies are avoided, and findings are put into practice sooner.
Support through the Workgroup of Medical Ethics Committees
The workgroup of Medical Ethics Committees already stand up for the foundation of a clinical trial registry in 2003. In March 2013 the workgroup spoke in favour for the need of a registration obligation and for the implementation of this demand by statute. The president of the board of the German Medical Ethics Committee workgroup supports the German Clinical Trials Register through its membership in the scientific advisory board.