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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

MULTIDISCIPLINARY RESEARCH PROJECTS ON PERSONALISED MEDICINE; DEVELOPMENT OF CLINICAL SUPPORT TOOLS FOR PERSONALISED MEDICINE IMPLEMENTATION

Alternative title: Multidisiplinært forskningsprosjekt på temaet Persontilpasset Medisin- Utvikling av kliniske støttevertøyer

Awarded: NOK 2.9 mill.

The overarching aim of this proposal is to turn the ill-defined, little understood and poorly predictable concepts of “loss of response” and “flares” in the treatment of RA into entities that are possible to assess in research studies, to investigate their occurrence, predictors and consequences, and to implement these findings into clinical care. This proposal is built on an ongoing collaboration among the partners behind this proposal, which aims at investigating and implementing predictors of primary response to anti-rheumatic drugs in RA. To this end, we have identified, extracted, harmonised, enriched (through linkage with other national register data available in the Scandinavian countries, and through new biomarker and genetic analyses based on stored blood sample) and pooled an impressive amount of individual RA treatment data (from clinical research studies, clinical trials, and clinical registers) that form the world’s by far largest and most detailed RA treatment cohorts, uniquely positioned to serve as underpinning also for this proposal. Indeed, we will use these data to devise definitions for “loss of sustained response” and “flares”, assess their predictors and consequences, and also seek to develop decision support tools so that these insights may directly benefit patients and care-provides. Expected outputs include: i) operational definitions of the concepts of (loss of) “sustained remission” and “flares” in RA, ii) a better understanding of their occurrence in clinical practice, iii) a better understanding of what the occurrence of these states is associated with and their consequences iv) the identification of predictors and prediction models that may be used to select RA treatments with the highest chance of sustained remission and the lowest risk of flares given the individual patient’s characteristics, and v) clinical tools, such as patient-centric e-health solutions that can be used by the individual and in routine clinical care.

Rheumatoid Arthritis (RA) is a heterogenous clinical syndrome characterised by a burden for the individual (pain, functional impairment, co-morbidities) and for society (medication costs, reduced work ability). RA displays a significant variation in clinical presentation, response to therapy, and longer-term outcomes. With few and crude predictors available, our current means for an individualised strategy are limited. A personalised medicine (PM) approach to RA requires new biomarkers, and algorithms, to support diagnosis and choice of effective treatment. For PM to transform clinical rheumatology practice, new tools to bring such algorithms to patients and health care are needed. For a number of reasons, the prospects for PM in RA are now much better than only a few years ago, but require a comprehensive approach including novel data and stakeholder collaboration. ScandRA builds on our successful international collaboration that is a joint effort between academia, health care, patients, industry and SMEs in biomarker technologies, data interoperability and e-health, and on our preliminary results from discovery science to health care transformation. In the Scandinavian countries, we have collected enormous amounts of information on patients with RA in our longitudinal prospective registers and biobanks, the largest and most detailed worldwide. We are now uniquely positioned i) to make detailed clinical data on RA disease activity, treatment, and life-style available for joint analyses with novel genomic- and biomarker-data from blood samples from these cohorts, ii) to take the next step, towards integration of the emergent results into clinical practice. Planned work include i) knowledge generation from novel analyses of our RA data, ii) value creation through development of decision support tools based on these insights, and iii) work with the ethical, legal and social challenges that are necessary for successful implementation.

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering