This Q&A has been prepared to answer questions about HONEUR and related topics.
HONEUR (Haematology Outcomes Network in Europe) is a new, Janssen-led collaboration amongst data centres in Europe, working together to scale up research on haematological malignancies. The overarching goal is to create a future where patients with haematological malignancies across Europe receive the best treatments because the power of Real World Data is being maximised.
The HONEUR platform will connect networks of specialist centres across Europe which have data on patients with haematological malignancies, whilst data is protected and stays within the centres. Researchers, including those working at these centres, will be able to use new analytics tools to securely analyse large volumes of data on a European scale. This will facilitate the generation of new Real World Evidence about these cancers, e.g., their possible causes and trajectories, biological markers of the cancer types and their severity, and the effectiveness of different treatments.
Real World Data is health data being recorded in the real world under everyday circumstances, as opposed to a clinical trial. This data could be generated by anyone active in the healthcare system, e.g., physicians, patients, administrative personnel, etc. It is usually held in hospital and GP electronic health record systems, and by patients in personal health records and various apps. When Real World Data are analysed and interpreted, the new evidence (knowledge) generated from this is called Real World Evidence.
RWD is very different from clinical trial data, as it reflects the full 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 will also help identify unmet patient needs, contribute to efficient methodology prior to clinical research being initiated, track treatment outcomes in the real world, inform effective decisions on Research & Development; and better data can contribute to better knowledge, potentially resulting in better treatments and/or patient outcomes.
The research initiated through the HONEUR network will include – among others – the generation of new RWE on risk factors for haematological malignancies, disease stratification, treatment patterns, short- and long-term health outcomes. Janssen aims to use the network, as an HONEUR research participant, to generate evidence to support its reporting requirements to medicines regulators and to national Health Technology Assessment agencies. It may also generate evidence that might serve as the basis for future outcomes-based payment models.
The HONEUR network is based on the principle that participants have local governance and keep control of their own data at all times. The original source data is locally transformed to a common data model structure. With the HONEUR setup, the subject level data in the common data model structure is not shared and stays local. Participating sites don’t need a physical connection with the central platform: the actual analysis is carried out locally and analysis results are only shared with the central HONEUR portal upon explicit interaction from the participating site. Also, for the exchange and storage of results, HONEUR is ensuring proper data protection: results are transferred to the HONEUR portal using the highest security standards. Also, once the results are stored at the portal itself, they are protected by encryption.
The entire HONEUR platform is specifically designed with patient privacy in mind. Firstly, all local data are pseudonomised, and in most cases, only aggregated and/or anonymised results are exchanged within the central HONEUR portal. No external access to this data repository is possible.
The transfer of results happens over a secure connection, and on the portal itself, results are encrypted and only accessible to the researchers who participated in the study. In all circumstances, the applicable data protection rules and regulations are complied with and appropriate privacy safeguards are put in place.
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ITEM CODE: CP-73766 | DATE OF PREPARATION: FEBRUARY 2019