ATHENA is a project that aims to set up a federated privacy-preserving platform in which real-world data from patients in our partner hospitals is gathered and analyzed using machine learning. Based on these analyses, it will be possible to precisely tailor treatment to the patient. Two specific types of cancer, multiple myeloma and bladder cancer, are used as pilot cases. However, it is the goal of the project to gain insights in the process of platform development in a manner that translation to other disease areas and institutions will be possible. This innovative project is a collaboration between academic and industrial partners, is led by Janssen and has been funded by the Flemish government.
What is the scope of ATHENA?
The first objective of ATHENA is to set up a federated privacy-preserving platform where patient data from different partners can be gathered, processed and analyzed. Secondly, algorithms will be established which use this clinical patient information to propose biomarkers and optimal care pathways for diagnosis and treatment. Since the two pilot disease areas are multiple myeloma and bladder cancer, the project will result in concrete recommendations for care of patients with the according malignancies. Finally, the entire platform will serve as an example for similar initiatives in other disease areas, thereby leading to improvement of care for many patients.
What are Real-World Data (RWD) and Real-World Evidence (RWE)?
Real-world data is data (such as patient characteristics, omics, etc.) coming from patients in a real clinical setting. This can be opposed to data obtained from conventional clinical trials, which result from a select group of patients (non-representative of the population) in a somewhat artificial setting.
Real-world evidence is clinical proof resulting from analysis of real-world data. For instance, when real-world data indicates that elderly patients receiving a certain type of drug do not recover as well as patients prescribed a different drug, there is real-world evidence that the first drug type is non-optimal for elderly patients. This is evidence that can guide healthcare professionals in establishing the correct therapy for a specific patient.
Why is RWD important?
In general, real-world data is very different from clinical trial data as it offers a broader diversity of patients who could develop the disease under study. It reflects the wide variation in how diseases like are diagnosed and treated. Furthermore, more information on the patient-level is available as patients can be followed as long as needed, this 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.
When working with real-world data, one has to keep in mind that these data is also somewhat harder to integrate, as it is initially less standardized (between physicians, hospitals, etc.). However, using the appropriate strategy and sufficient care, it is possible to utilize this wealth of data for improving patient care.
What type of questions can be answered with ATHENA?
ATHENA is a pioneering project as it will be the first time in Belgium a data-integrating platform of such scale will be set up. Initially, ATHENA uses two types of cancer, multiple myeloma and bladder cancer as pilot diseases. At the end of the project, it will thus be possible to provide answers to questions such as, which biomarkers are interesting to monitor upon disease progression and which treatment is optimal for my particular patient. However, ATHENA goes beyond the study of individual diseases. As the platform that will be set up, can be translated to other disease areas as well, the implications on a broader scale are significant. ATHENA know-how and expertise can be used to model similar initiatives.
What is Feder8 and what information is stored on this ATHENA data portal?
The ATHENA portal is the core of the network. It’s a secured environment that is only accessible to ATHENA 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 ATHENA portal – only aggregated results or a research question.
How are data secured and patient privacy protected?
The ATHENA network is based on the principle that data partners (being local hospitals) retain governance and keep control of their own data at all times. The original source data are transformed at the data partner’s site to a common data model (OMOP guidelines, more information available at OHDSI). If a data partner agrees to participate in an analysis, this will be carried out locally and the results will be posted on the central ATHENA portal. In the seldom-seen case that a research question can only be answered with patient-level data (and upon explicit agreement), pseudonymized data can be shared. All data are always protected by encryption.
How can I (as a patient, healthcare professional or medical institution) participate in this study?
At the moment the ATHENA consortium is composed of several hospitals, which will collect data of patients with multiple myeloma and bladder cancer, after their consent. Patients eligible for the study will be informed by their physician.
For healthcare professionals or hospitals outside of the consortium, it is currently not possible to join the network. However, in later stages of the project, novel data partners can possibly join. This will be communicated in due time.