FAQs

HONEUR (Haematology Outcomes Network in Europe) is a Janssen-led initiative that is all about collaboration. Rather than creating a central data repository, the HONEUR federated data network enables partners to keep full control over their own data and the analysis. By bringing together data centres in Europe to scale up research on haematological malignancies, it aspires to create a future where patients with haematological malignancies across Europe have improved outcomes because the power of Real-World Data and Real-World Evidence is being maximised.

The HONEUR platform is designed to connect networks of data sources across Europe, which have data on patients with haematological malignancies. Data always stays protected and network partners keep control of their data at all times. Data partner are able to use new tools to securely analyse large volumes of data on a European scale. This will facilitate the generation of new Real-World Evidence about haematological malignancies, e.g., their possible trajectories, biological markers of the cancer types and their severity, and the effectiveness of different treatments.

Innovative Medicines Initiative (IMI) definitions:

Real-World Data (RWD) is an umbrella term for data regarding the effects of health interventions (e.g., benefit, risk, and resource use) that are not collected in the context of conventional randomised clinical trials (RCTs). RWD can be obtained from many sources including patient registries, electronic medical records, and observational studies.

Real-World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of RWD.

RWD is very different from clinical trial data as it offers a broader diversity of patients who could develop haematological malignancies. It reflects the wide variation in how diseases like cancer are diagnosed and treated, and usually spans the full disease history from before diagnosis to long-term survival or death. It will include information about how other conditions are being treated in parallel to the cancer, and how these treatments may interact.

In summary, RWD complements the results from randomised clinical trials and expands knowledge on treatment outcomes in the real world. It deepens understanding of disease epidemiology and the impact on patients and public health. It also provides insights for improved patient care and benefits future research.

The power of HONEUR lies in enabling data analysis on multiple data sets with methodological and statistical possibilities. By analysing data from multiple partners, common research questions on overall survival, time to next treatment, or treatment sequencing can be answered. These are only a few examples - as HONEUR evolves, answers to other questions will follow.

The HONEUR portal is the core of the network. It’s a secured environment that is only accessible to HONEUR partners. It offers different functionalities to the partners. A data catalogue contains a description of various data sets of data partners and how to engage with them. The study catalogue is the central place where a study request gets initiated, and where the analysis script and eventually aggregated results will be stored (visible to study participants only). No patient-level data are stored on the HONEUR portal – only aggregated results or a research question.

The HONEUR network is based on the principle that data partners have local governance and keep control of their own data at all times. The original source data are transformed at the data partner’s site to the OMOP common data model, which always stays local.

If a data partner agrees to participate in an analysis, this would be carried out locally and the results would be posted on the central HONEUR portal. In the base case, all results are being aggregated. In the seldom-seen case that a research question can only be answered with patient-level data (and upon explicit agreement), pseudonymised data can be shared. All data are always protected by encryption.

Janssen remunerates at Fair Market Value for efforts arising from the implementation of HONEUR during the set-up phase as well as for research questions being carried out. Additionally, Janssen pays a yearly fee for performed feasibility queries.