Beyond public dashboards: Leveraging Germany’s National Cancer Registry for pharmaceutical research – Insights from a ZfKD Research Initiative

The ZfKD offers two distinct levels of data access. First, a publicly available data browser allows users to explore aggregated epidemiological statistics, including incidence, prevalence, mortality, and survival. These analyses are available at a relatively coarse level of disease classification, typically based on three-digit ICD-10-GM codes or broader cancer groupings, rather than more granular classifications, for example, on four-digit ICD-10-GM codes or ICD-O-3 codes. As such, the publicly available data browser offers cost-effective, efficient access to high-level epidemiological analyses and is widely used to support descriptive evidence in German AMNOG dossier submissions. However, the aggregated nature of the data limits its applicability to research questions requiring more detailed disease definitions or refined patient stratification.

Second, beyond this publicly available data browser, the ZfKD also provides application-based access to more detailed datasets for approved research projects under §8 of the German Federal Cancer Registry Data Act (Bundeskrebsregisterdatengesetz, BKRG).  

Through this pathway, applicants may request expanded epidemiological or clinical datasets. The epidemiological dataset provides information covering the years 1999-2023, including patient demographics, cancer diagnoses, tumour characteristics, disease course, and vital status. In addition, access to the clinical dataset is available for more recent years (2020-2023) (2024 data are expected to become available in mid-2026), which allows analyses of detailed treatment pathways, including surgical procedures, radiotherapy, systemic therapies, and selected follow‑up events. Access to these datasets is subject to a structured application process and a comprehensive assessment of data protection and re-identification risks conducted by the ZfKD and its scientific committee. Approved applications, including their corresponding abstracts, are published in a public directory on the ZfKD website. 

For pharmaceutical companies, this formal access pathway enables analyses that are not feasible with aggregated data alone, particularly for complex RWE and epidemiological research questions requiring stratification by clinical and biological characteristics.

In addition to ongoing ZfKD projects in collaboration with pharmaceutical companies, Cencora conducted an internally sponsored initiative to demonstrate the analytical potential of formally accessing these detailed clinical cancer registry datasets. The underlying study is titled “Treatment Pathways and Clinical Characteristics Among Patients with Metastatic Breast Cancer in Germany: A Retrospective Descriptive Analysis with Data from 2020 to 2023.” (https://edoc.rki.de/handle/176904/12927).

This research initiative focuses on patients with newly diagnosed metastatic breast cancer (mBC) in Germany and aims to improve the understanding of real‑world treatment patterns and patient characteristics in this population. Breast cancer remains the most common cancer among women in Germany, and metastatic disease is associated with substantial morbidity and mortality. Advances in systemic therapies and biomarker-driven treatment strategies have increased the complexity of clinical decision-making, underlining the need for detailed real-world data.

Access to the ZfKD clinical cancer registry data for this research initiative required submission of a formal application under §8 BKRG. The application included a comprehensive study outline describing the scientific objectives, methodological approach, and analytical endpoints of the project.

A key component of the application process was the detailed specification and justification of the requested variables. This included demographic variables, tumour-related information (ICD 10-GM and ICD-O codes, tumour node metastasis staging, grading, and metastasis sites), therapy-related variables (surgical procedures, radiotherapy, and systemic treatments), and vital status information. The variable selection was aligned with the study objectives and designed to minimise data use to what was strictly necessary for the research purpose.

In parallel, extensive documentation on data protection and information security was required. This included a project‑specific data protection statement describing the purpose of data processing, access restrictions, storage environment, and data deletion procedures, as well as organisation-wide documentation of technical and organisational security measures. These measures included certified information security management systems, controlled access environments, and clear rules governing data storage, backup, and deletion.

Importantly, the ZfKD conducts an independent assessment of the risk of re-identification for each data request. Where necessary, risk-mitigation measures such as reduced granularity of certain variables (e.g., age) or the provision of aggregated outputs may be applied. In the present research initiative, individual-level data were processed exclusively within a secure environment, and study results are reported only in aggregated form.

The research initiative illustrates the high level of data protection and governance associated with ZfKD data access. Processing the data is strictly limited to the approved research purpose, and access is restricted to named project personnel with defined roles. Data storage takes place within a secure infrastructure located in the European Union, and data are deleted upon completion of the project.

From a pharmaceutical industry perspective, these requirements necessitate careful planning and close collaboration between scientific, legal, and data protection teams. At the same time, they provide assurance to regulators, data providers, and the public that sensitive health data are handled responsibly and in compliance with applicable legal frameworks, including the national cancer registry legislation and the General Data Protection Regulation.

This internal research initiative demonstrates that industry-led research using detailed ZfKD clinical cancer registry data is feasible within the existing legal and governance framework. As experience with the application process grows, workflows continue to mature, and as the dataset is expanded on an annual basis, ZfKD data may play an increasingly important role in oncology evidence generation in Germany.

For pharmaceutical companies, particularly those developing or marketing oncology therapies, early consideration of cancer registry data in evidence‑generation strategies may offer valuable insights into real-world treatment pathways and patient populations. When combined thoughtfully with claims data and other RWE sources, ZfKD data have the potential to enhance the robustness and credibility of analyses supporting health technology assessment, market access, and broader strategic decision-making in the German healthcare system.