Periodic Reporting for period 1 - CLAIMS (CLinical impact through AI-assisted MS care)
Okres sprawozdawczy: 2023-06-01 do 2024-05-31
Multiple sclerosis (MS) is a devastating immune-mediated disorder of the central nervous system. Since there is no cure available yet for MS, the primary therapeutic goal for MS patients is to slow down disability progression and to reduce relapses at early stages of the disease. Despite many available disease modifying treatments (DMTs), the large heterogeneity of the disease which is further complicated by the high prevalence of comorbidities and multi-pharmacy, results in a poor and variable treatment response in a real-world setting.
The CLAIMS project is a public-private partnership aiming to address this and make precision medicine for MS patients a reality through data-driven prognosis and treatment optimisation, in order to better slow down disease progression. We will develop, validate and submit for regulatory approval a companion platform, which offers the MS care team a holistic view of the patient through the visualization of relevant clinical and subclinical biomarkers and the prediction of the expected disease trajectory under different treatment options. For biomarker extraction and treatment prediction, state-of-the-art technologies that allow a reliable and scalable implementation across the world will be used. We believe this platform will initiate the paradigm shift from a trial-and-error, experienced-based treatment of MS patients to a first-time-right, value-based holistic treatment management, and will, hence, improve patient outcomes at a lower total cost of care, enhance patient experience and improve the well-being of the care team.
https://www.claims.ms/(odnośnik otworzy się w nowym oknie)
The CLAIMS project is a public-private partnership aiming to address this and make precision medicine for MS patients a reality through data-driven prognosis and treatment optimisation, in order to better slow down disease progression. We will develop, validate and submit for regulatory approval a companion platform, which offers the MS care team a holistic view of the patient through the visualization of relevant clinical and subclinical biomarkers and the prediction of the expected disease trajectory under different treatment options. For biomarker extraction and treatment prediction, state-of-the-art technologies that allow a reliable and scalable implementation across the world will be used. We believe this platform will initiate the paradigm shift from a trial-and-error, experienced-based treatment of MS patients to a first-time-right, value-based holistic treatment management, and will, hence, improve patient outcomes at a lower total cost of care, enhance patient experience and improve the well-being of the care team.
https://www.claims.ms/(odnośnik otworzy się w nowym oknie)
During the first year, we initiated the retrospective data collection study (called RECLAIM). We developed the study protocol and accompanying documentation (data management plan (DMP), data protection impact assessment (DPIA) and data processing agreement (DPA)). The clinical partners obtained their IRB approvals for the study. From a technical perspective, we set up the data flow, the analysis pipelines and the database with the accompanying common data model. Data transfers and analyses were initiated at the end of this first year and work on this study will continue during the 2nd year of the project.
While waiting for RECLAIM dataset, in-house or publicly available MRI datasets were used to already start with the AI model developments. Both Machine-learning and generative AI models were tested to classify patients in to subtypes according to their different progression paths.
In addition to setting up the RECLAIM study, we’ve also made great progress on several technical aspects of the project related to the development and implementation of biomarkers to monitor disease progression in more detail. As such, we’ve developed and deployed two new AI-driven pipelines, one for the automatic quantification of paramagnetic rim lesions (PRL) and one for quantifying spinal cord atrophy at the C2/C3 level. Additionally, we developed and validated two smartphone-based tests to better monitor disease progression: the icompanion Symbol Test and the icompanion Finger Dexterity Test. Both tests are ready and are currently being implemented in the icompanion app, making them available to patients when the next version of the app releases (Q3 2024).
Last but not least, we implemented the first version of a true holistic companion platform. This platform builds upon the previous version of the icompanion HCP portal and has received a major UX/UI overhaul, focussing on displaying the information to the treating physician which is most relevant towards making an informed decision on treatment and care for a patient. In addition, several new functionalities were implemented (MRI integration, EMR integration through smart on FHIR, a fully functional eCRF module, a revised visit preparation module and more…).
While waiting for RECLAIM dataset, in-house or publicly available MRI datasets were used to already start with the AI model developments. Both Machine-learning and generative AI models were tested to classify patients in to subtypes according to their different progression paths.
In addition to setting up the RECLAIM study, we’ve also made great progress on several technical aspects of the project related to the development and implementation of biomarkers to monitor disease progression in more detail. As such, we’ve developed and deployed two new AI-driven pipelines, one for the automatic quantification of paramagnetic rim lesions (PRL) and one for quantifying spinal cord atrophy at the C2/C3 level. Additionally, we developed and validated two smartphone-based tests to better monitor disease progression: the icompanion Symbol Test and the icompanion Finger Dexterity Test. Both tests are ready and are currently being implemented in the icompanion app, making them available to patients when the next version of the app releases (Q3 2024).
Last but not least, we implemented the first version of a true holistic companion platform. This platform builds upon the previous version of the icompanion HCP portal and has received a major UX/UI overhaul, focussing on displaying the information to the treating physician which is most relevant towards making an informed decision on treatment and care for a patient. In addition, several new functionalities were implemented (MRI integration, EMR integration through smart on FHIR, a fully functional eCRF module, a revised visit preparation module and more…).
Several advances towards realising the envisioned platform and its impact have been made throughout the first year and some of these are already having a direct impact today.
The healthcare practitioner portal for the icompanion app which was developed in WP3 has been released to users of the portal under the new MDR regulation. Through its improved UX/UI, neurologists now have a dashboard at hand which summarizes the most important data for them (MRI, treatments, patient reported outcomes, …), improving their workflow and contributing to a more holistic view of the patient and their disease progression.
The initial versions of the pipelines to automatically quantify paramagnetic rim lesions (PRL) and spinal cord atrophy are available for users globally now, but currently only in a research setting. This is the first step towards realising the impact of these new tools, as once they are regulatory cleared for clinical use these tools will allow to transition from a subjective assessment of these biomarkers towards a fully automated and quantitative assessment, reducing workload issues for physicians while enabling better monitoring of disease progression for patients.
The icompanion app has seen significant improvements throughout the first year of the project, which greatly increase the value it brings to both patients and their neurologists. The visit preparation module allows to focus on what patients really want, and thus improving their quality of life. The revised knowledge center increases patient empowerment, and we now have two smartphone-based tests ready for integration into the icompanion app: the icompanion Symbol Test and the icompanion Finger Dexterity Test. These tests will allow remote and continuous monitoring of two clinically important measures for disease worsening.
Lastly, we’ve set up the infrastructure and governance structure for the RECLAIM study and data collection is ongoing. A joint governance body will be put in place to guide scientific insights generation.
The healthcare practitioner portal for the icompanion app which was developed in WP3 has been released to users of the portal under the new MDR regulation. Through its improved UX/UI, neurologists now have a dashboard at hand which summarizes the most important data for them (MRI, treatments, patient reported outcomes, …), improving their workflow and contributing to a more holistic view of the patient and their disease progression.
The initial versions of the pipelines to automatically quantify paramagnetic rim lesions (PRL) and spinal cord atrophy are available for users globally now, but currently only in a research setting. This is the first step towards realising the impact of these new tools, as once they are regulatory cleared for clinical use these tools will allow to transition from a subjective assessment of these biomarkers towards a fully automated and quantitative assessment, reducing workload issues for physicians while enabling better monitoring of disease progression for patients.
The icompanion app has seen significant improvements throughout the first year of the project, which greatly increase the value it brings to both patients and their neurologists. The visit preparation module allows to focus on what patients really want, and thus improving their quality of life. The revised knowledge center increases patient empowerment, and we now have two smartphone-based tests ready for integration into the icompanion app: the icompanion Symbol Test and the icompanion Finger Dexterity Test. These tests will allow remote and continuous monitoring of two clinically important measures for disease worsening.
Lastly, we’ve set up the infrastructure and governance structure for the RECLAIM study and data collection is ongoing. A joint governance body will be put in place to guide scientific insights generation.