Abstract

Despite the ever-progressing technological advances in producing data in health and clinical research, the generation of new knowledge for medical benefits through advanced analytics still lags behind its full potential. Reasons for this obstacle are the inherent heterogeneity of data sources and the lack of broadly accepted standards. Further hurdles are associated with legal and ethical issues surrounding the use of personal/patient data across disciplines and borders. Consequently, there is a need for broadly applicable standards compliant with legal and ethical regulations that allow interpretation of heterogeneous health data through in silico methodologies to advance personalized medicine. To tackle these standardization challenges, the Horizon2020 Coordinating and Support Action EU-STANDS4PM initiated an EU-wide mapping process to evaluate strategies for data integration and data-driven in silico modelling approaches to develop standards, recommendations and guidelines for personalized medicine. A first step towards this goal is a broad stakeholder consultation process initiated by an EU-STANDS4PM workshop at the annual COMBINE meeting (COMBINE 2019 workshop report in same issue). This forum analysed the status quo of data and model standards and reflected on possibilities as well as challenges for cross-domain data integration to facilitate in silico modelling approaches for personalized medicine.

Highlights

  • A key strategic objective of EU-STANDS4PM is to engage with relevant stakeholders

  • EU-STANDS4PM consulted the COMBINE (Computational Modelling in Biology Network) community to address crucial requirements with respect to the development of data and model standards as well as data integration tasks in research and clinic, including ethical and legal aspects. These areas were discussed at the annual meeting of COMBINE in moderated round table workshops covering six central topics presented below and that conclude in a first set of recommendations to key actors

  • A key output of the discussed workshop topics was a summary of challenges associated with the implementation of data-driven in silico methodologies in personalized medicine and clinical practice

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Summary

Introduction

A key strategic objective of EU-STANDS4PM is to engage with relevant stakeholders. Through specific awareness actions, including workshops, the project provides a forum to assess strategies for health data integration (such as genetic, expression, proteomics, demographic, clinical, and lifestyle exposures) as well as. This proactive networking process is central to the major deliverable of EU-STANDS4PM, which is to jointly develop universal standards as well as guidelines and recommendations for in silico methodologies relevant for personalized medicine in a concerted action To initiate this process, EU-STANDS4PM consulted the COMBINE (Computational Modelling in Biology Network) community to address crucial requirements with respect to the development of data and model standards as well as data integration tasks in research and clinic, including ethical and legal aspects. EU-STANDS4PM consulted the COMBINE (Computational Modelling in Biology Network) community to address crucial requirements with respect to the development of data and model standards as well as data integration tasks in research and clinic, including ethical and legal aspects These areas were discussed at the annual meeting of COMBINE in moderated round table workshops covering six central topics presented below and that conclude in a first set of recommendations to key actors

Standards as drivers for reproducibility and data quality
Community and formal standards
Formal standards
Community standards
Challenges and hurdles
Pitfalls in developing and harmonizing standards
Standards relevant for personalized medicine
Lack of common data schemes
Lack of data harmonization
Integration of clinical and research data
Individual level integration
Integration of variables
Conclusions
Healthcare providers purchasing and developing electronic healthcare systems
Journals
Research groups
National and regional health data providers
Policy makers
Full Text
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