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Statistics

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.

Usage of DRKS

Currently, about 5000 registrants use the DRKS annually to register or update their studies. DRKS studies are accessed over 30,000 times per month via Google search (as of 2025).

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). In 2024, there was a slight decline in registrations for the first time.

Statistics of studies registered in DRKS for the years 2009 - 2024. In 2024 there were 1869 registrations.
DRKS registrations per year. Source: BfArM

Ratio of prospectively to retrospectively registered interventional studies in the DRKS

In accordance with the requirements of the Declaration of Helsinki, WHO and ICMJE, all clinical studies should be prospectively registered. The proportion of prospectively registered interventional studies in the DRKS is currently around 60%.

Ratio of prospectively versus retrospectively registered interventional studies per year. The percentage increased constantly from around 45% in 2010 to almost 70% in 2024.
Ratio of prospectively versus retrospectively registered interventional studies per year. Source: BfArM

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 CTIS (EU Clinical Trials Information System) or were registered in the EU-CTR (EU Clinical Trials Register) before 31.01.2023. 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.

Statistics of IST/IIT studies registered in DRKS for the years 2010 - 2024. Since 2012, it has been constant at about 90%.
Ratio of investigator-initiated studies to non-investigator-initiated studies per year. Source: BfArM

Ratio of interventional versus non-interventional studies

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

Statistics of interventional and non-interventional studies registered in the DRKS from 2010 - 2024. The percentage of non-interventional studies increased steadily and is at about 60% since 2023.
Ratio of interventional studies versus non-interventional studies per year. Source: BfArM

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 a snapshot of the percentage of registered studies in the DRKS that have reported study results, broken down by registration year:

Statistics of studies completed by WHO standards in the DRKS from 2010 to 2024. Approx. 30% of all studies up to 2018 were ultimately registered with publication of results, in the years thereafter the number decreases linearly to 1% in 2024.
Completed studies with publication of results by registration year, as of January 17, 2025. Source: BfArM

Percentage of studies that have not been updated for more than 1 year

After a study has been registered for the first time, the study data set should be regularly updated until it is finalized with the study results. Despite automatic reminder emails, the last update of a high proportion of studies was more than 12 months ago (orange bar). The graphic shows a snapshot.

Proportion of studies not updated for more than a year. The proportion of studies not updated for more than one year lies constantly at about 60%. The percentage of complete data sets is around 40% until 2016, then slowly decreases to 4% in 2023.
Proportion of studies not updated for more than a year, snapshot taken on January 10, 2025. Source: BfArM

Percentage of studies for that Individual Patient Data is provided

The anonymised sharing of individual patient data collected in clinical trials can increase transparency, improve understanding of individual studies and support the reuse of data for secondary research. For studies registered in the DRKS between 2023 and 2024, this is only the case fpr just under 30%.

IPD sharing statement of all studies registered in 2023 and 2024. 18% of studies have an IPD sharing plan, 82% don't.
IPD sharing statement of all studies registered in 2023 and 2024. Source: BfArM

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 the end of 2023, approx. 600 COVID-19 studies were registered in the DRKS.

Statistics of COVID studies registered in the DRKS from March 2020 to May 2023. 42 studies in April 2020 are opposed by three in December 2023.
Registered COVID-19 studies per month, from March 2020 to December 2023 Source: BfArM

Feedback

Do you think that statistics are missing? Please feel free to contact us: drks@bfarm.de