About the Project

The DRKS offers the possibility to search for information on planned, ongoing and completed clinical studies or to make own studies accessible to others via registration. It was set up by the Institute of Medical Biometry and Statistics of the University Medical Centre Freiburg as part of a project of the Federal Ministry of Education and Research (BMBF) and transferred to permanent operation at the German Institute of Medical Documentation and Information (DIMDI) on 1 July 2017. On 26 May 2020 the DIMDI was incorporated to the Federal Institute for Drugs and Medical Devices (BfArM).

The DRKS has been recognised as a WHO Primary Registry since October 2008. It thus fulfils the requirements of the ICMJE, whose members adopted the prospective registration of clinical trials as a prerequisite for publication in leading medical journals as early as 2004. It also fulfils the requirement for registration of the Declaration of Helsinki. For more information see Networking

Users of the DRKS

Different target groups benefit from the German Clinical Trials Register:

• Patients
• Physicians, therapists, pharmacists
• Non-medical professions (physiotherapy, occupational therapy, speech therapy, nursing, midwifery, etc.)
• Self-help groups
• Ethics Committees
• Scientists / basic researchers
• Pharmaceutical industry
• Research funding institutions
• Authorities
• Decision-makers
• Reviewers

Patients and the doctors treating them can use this portal to find out about clinical trials being conducted in Germany and specifically search for suitable trials to participate in. Conversely, investigators can use the DRKS to provide information about their studies. Self-help groups are offered an independent overview of new and ongoing studies through this register, which can help them to inform their members.

Clinical research usually takes place in networks. On the one hand, study registries can be a platform for initiating new collaborations between basic researchers and clinical researchers; on the other hand, they are an instrument for making this networked research visible. The review of clinical studies, which takes place at different levels and in different contexts (e.g. at ethics committees and authorities), can also be supported by independent and comprehensive information on the evidence situation and on ongoing and completed studies. Furthermore, the scientific preparation of meta-analyses is facilitated. Last but not least, the pharmaceutical industry can gain an impression of the expertise and scientific focus of a location.

Background knowledge on clinical trials in Germany is also needed when setting the course for research funding, location funding or decisions in the health care system.

Detailed information on the studies recorded in the DRKS and a comparison with other registries can be found under Statistics.

The goals of the DRKS are to:

• provide an up-to-date overview of patient-oriented clinical trials in German-speaking countries.
• provide all users with easy and free access to the register.
• inform the public in German and English.
• provide, in cooperation with ethics committees, the basis for scientific statements on the type and number of studies conducted in Germany.
• support sponsors in the planning of clinical trials.
• promote the quality of clinical research in Germany through transparency of study data.
• provide the necessary information and create the conditions for cooperation between different clinics and working groups.
• support ethics committees and authorities in fulfilling their review and supervisory tasks.
• enable ICMJE-compliant registration of planned clinical trials.