The following statistical evaluations intended to illustrate the development of the registry, as well as to provide an overview of the content and type of studies included in the DRKS. They also show the extent to which the goals formulated by the WHO for primary registries (e.g. promotion of the proportion of prospectively registered studies) have been achieved.

The content on statistics is currently under construction and will be expanded in the following months.

Usage of DRKS

Currently, about 5000 registrants use the DRKS annually to register or update their studies. The public search protal records an average of 30,000 searches per year (as of 2023).

Development of registrations per year in DRKS

Since the start of the registry in 2008, more studies have been registered in the DRKS every year. The two COVID pandemic years, in which significantly more studies were registered, are noticeable. However, the COVID studies conducted during this period cannot be held solely responsible for this peak (2020 = 242 studies; 2021 = 197 studies).

Ratio of prospectively to retrospectively registered studies in the DRKS

The WHO stipulates that at least 50% of all clinical trials in a WHO primary registry should be prospectively registered. Since 2016, this target has been achieved and there is a slight trend towards an increase in the proportion of prospectively registered studies. If only the interventional studies of the DRKS are considered, a similar distribution can be seen. As a long-term goal and in accordance with the requirement of the Declaration of Helsinki, the DRKS supports the prospective registration of all clinical trials.

Investigator Initiated Trials (IIT) in DRKS

The rate of registered investigator-initiated studies per year has remained high at about 90 % since 2010. These studies are usually conducted by universities.

Commercial clinical trials of medicinal products must be registered in the EU-CTR (EU Clinical Trials Register) or, at the latest since 31.01.2023, in the CTIS (EU Clinical Trials Information System). An additional registration of these studies in another WHO primary register is not required or explicitly not desired by the WHO, if there are no specific reasons.

Ratio of interventional versus non-interventional studies

The proportion of non-interventional studies (observational studies) has increased since the DRKS was established and was just over 50 % in 2022.

COVID-19 studies since March 2020

After the WHO officially declared COVID-19 a global pandemic in March 2020, the highest monthly number of registered COVID-19 studies in the DRKS was already reached in the following month of April. From March 2020 to May 2023, approx. 600 COVID-19 studies were registered in the DRKS.

Completed studies with results publication

The WHO stipulates that results should be included in the study dataset no later than 12 months after completion of the study. This may also include a link to a journal publication.

The following chart shows the percentage of registered studies in the DRKS that have reported study results, broken down by registration year (as of 18. January 2024)