Better use of health data in clinical trials. Explainable AI and Digital Health to unlock the potential of clinical registries.
The political paper “Action Plan for Clinical Studies (2021–2025)” was recently released in Norway by the Ministry of Health and Care Services, presenting 9 areas of focus. At PubGene AS, in Oslo, Norway, we are developing Coremine Vitae. It is a digital health solution for personalised medicine powered by Vitae Evidence software, CE-marked as a Medical Device Software MDD Class I
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In this 3rd post of the series, I present how Coremine Vitae will contribute to better use of health data in clinical trials. This is the focus area 8 in the Norwegian government’s action plan for Clinical Studies.
Explainable AI and Digital Health will enable register-based randomised clinical trials (RRCT)
Traditional Randomised Clinical Trials (RCT) are complex and expensive to perform. Register-based randomised clinical trials (RRCT) are a new, more affordable methodology for collecting treatment and outcome data in an existing registry. In RRCT, eligible patients are identified and recruited from the registry. The patients’ existing baseline medical history is recorded in the registry. Data related to the intervention and the outcomes are captured in the registry.
What registries are available?
The nordics national clinical quality registers: Norwegian Registers, Swedish Registers, Danish Registers, Finish Registers. Companies such as PasientSky, Dips Arena and TietoEVRY build on openEHR, an international standard for building clinical data repositories that are future-proof and flexible. The various clinical applications: at a national level, helsenorge.no, The Welfare Technology program, SFM (Central Prescription Module), Helsedataprogrammet (Health Data Program), EPJ-løftet (improvement of GP EMR systems), and Helseplattformen in Central Norway are introducing FHIR for interactions based on data sharing.
How to unlock the potential of clinical data?
This is where Vitae Evidence comes in: the SaaS solution that I am making together with NLP and Data engineers to assist Coremine Vitae analysts. We are developing algorithms and tools to map pseudonymised patient profiles to PICO questions and their answers (Population, Intervention, Comparator, Outcomes) using knowledge from a broad range of information sources:
We are developing algorithms that continuously fetch and harmonise any text or external knowledge base and annotate it with biomedical concepts and clinical qualifiers in near-real-time. This makes personalised medicine information searchable. Then patient profiles (Case Summary) are translated into a set of de-identified search strategies. This is based on PICO questions and references inclusion/exclusion rules to compute a summary of findings.
Translational Bioinformatics to produce synthetic control arms
At the heart of most clinical trials, the question relates to determining the treatment effect for one agent versus placebo control. In synthetic control arms, placebo arms are modelled using information that has previously been collected instead of patients receiving a placebo. Vitae Evidence algorithms may generate synthetic control arms from historical control data in previously published clinical trials, real-world data, and data aggregated from the previously published scientific literature.
Digital Health to utilise the diversity of data sources about the population’s life and health and include so-called real-world data (RWD) in clinical studies
The overall solution is registered as a Medical Device Software and enables the collection of clinician and patient feedback and real-world outcomes.
We built our platform so that the more it is used, the smarter it gets. As more cases are registered and real-world feedback collected, more knowledge is made available for future patients.
Explainable AI and Digital Health will enable pragmatic clinical trial (PCT)
Physicians found that traditional clinical trials do not always translate to outcomes in typical practice. To address this limitation, A pragmatic clinical trial (PCT) focuses on the correlation between treatments and outcomes in real-world health system practice rather than focusing on proving causative explanations for outcomes.
The explanation provided by evidence-based medicine remains essential to understand the causation and to differentiate actual efficacy from placebo effects. That is why we develop a digital health solution that combines Evidence-Based Medicine and Real-World Research Principles.
The resulting insights are delivered on a Digital Health solution that enables a Real-World feedback loop:
Clinical Trials insights will prioritise clinical studies on multidisciplinary issues. The scope of clinical trials that include a greater variety of primary and secondary endpoints will generate a broader set of data.
Coremine Vitae reports provide insights on recruiting clinical trials matching the patient, including his molecular profile, values and preferences. We are developing a method to rank the relevance of those trials, and we will give the option to prioritise clinical studies on multidisciplinary issues.
The Nordic countries’ new vision for Nordic co-operation towards 2030 is for the Nordic region to become the world’s most sustainable and integrated region.
Our secure collaboration and remote monitoring module is based on the international software company CheckWare. The overall solution Coremine Vitae obtained CE-mark MDD Class I.
With our SaaS solution, we are aiming at making a positive impact in the lives of many. We are looking for innovative clinics and research centres in personalised medicine to co-create and pilot our new SaaS solution. Are you interested? Contact us for early access.
In case you’ve missed the previous articles:
- Norwegian Action Plan for Clinical Studies — The opportunities that lie in Translational Bioinformatics and Digital Health.
- Clinical trials will be an integrated part of patient care.
- How Translational Bioinformatics and Digital Health will contribute to increased opportunities for patients to participate in clinical trials
