Deliverables
The report will be based on an assesssment on current personalized medicine and systems medicine projects and their use of data standards and guidelines as well as for their needs and gaps in standardization with focus on Analyzing the interoperability and scalability of data and metadata standards specific for field domains egclinical data systems medicine bio banking etc or applied technology domains eg genomics proteomics metabolomics or modelling etc to ensure crossdomain and crosstechnology data integration The report will provide recommendations for the concerted use of domainspecific standards for complex workflows in personalizedmedicine and systems medicine
EU-wide mapping report on methodologies of risk prediction and progression patterns of common diseasesThis report will present a state of the art overview of methods for i risk prediction from polygenic risk scores to hybrid approaches that combine multiple types of molecular data with longitudinal clinical data as well as for ii response to therapy predictions including integration of several omics technologies genomics proteomics metabolomics etc with clinical and registry data and in silico prediction models to provide clinical guidance for optimal drug efficacy and safety
Assessment report on feasibility of CbA for H2020 projectsThis report publication will describe the outcome of the evaluation of cloudbased access CbA for integrated analysis of EU project data assessing the ease of access compute optionsspeed user support longterm support and other EUSTANDS4PM relevant aspects for making final recommendationsIndicative key topics1 Identification of key barriers relating to data access dissemination and governance that have been identified to hamper the advancement of Personalized Medicine and Data Science in general 2 Identification of key eligibility issues and other barriers with regard to the implementation of CbA in collaborative EU research projects3 Recommendations for future collaborative research projects with the aim to improve integrative analysis across data that are essential for personalized medicine and to simplify the current diversity in administrative ethical and legal requirements across Europe4 Overall dissemination of results from the consortium and collation of information to ensure proper distribution and project impact with regard to external EU projects and stakeholder communities
EU-wide mapping report on good practice examples for integrating phenotype and large scale dataThis report will provide a comprehensive collection of examples and good practice of current personalized medicine and systems medicine projects on the current use of data standards and minimal information guidelines as well as for their needs and gaps in relation to standardization issues for integrating phenotype and large scale data for predictive in slico models
Recommendations for standards that enable the development of predictive in silico models for the interpretation of health dataThis report will describe i European standard documents in the area of in silico models for personalized medicine and ii the need for standardization of longitudinal disease analysis as well as iii provide recommendations for identified gaps and needs
EU-wide mapping report on big data harmonization and integration methodologies for in silico modellingThis report will present a state of the art overview of methodologies for harmonization and integration of big data The report will identify and review different data integration approaches in the context of personalized medicine It will also assess the data sources provided by WP1 and their relevance for crossdisciplinary European health research projects and the future development of predictive in silico models
EU-wide mapping report on legally and ethically sustainable avenues for harmonization and integration of big data for in silico models in personalized medicineThis report will outline technically feasible as well as legally and ethically sustainable avenues for harmonization and integration of big data for personalized medicine into in silico modelsThe integration of Big Data into healthcare has received attention from an ethical and policy perspective but lacks focus on the particular integration of data for in silico models and the corresponding relevant legal regulations The proposed report will provide an in depth assessment of the key legal and ethical issues specific to data integration issues in relation to in silico models in order to lay the foundation for practical recommendations
EU-wide mapping report with focus on international databases collections and registriesThis report will describe a comprehensive catalogue of data resources relevant to personalized medicine that where appropriate leverages data catalogues developed within the European Open Science Cloud EOSC and the related and developing European Health and Innovation Cloud HRIC and a forward looking action plan with recommendations that will support responsible and secure data sharing and access to reference data across borders
EU-wide mapping report on legal and ethical considerations regarding data protection, clinical trials regulation and patient rights for predictive silico models in personalized medicineThis report will describe the outcomes of an in depth analysis regarding (i) international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in-silico modelling, and (ii) an assessment of the challenges and options this regulation provides for harmonization and integration of data in in-silico modelling. Despiste the existence of European law (GDPR and clinical trials regulation), there are still uncertainties regarding e.g. the impact of the GDPR in regards to this kind of data sharing. E.g. the continuing differences in the interpretation of anonymisation/pseudonymisation is a key example of this uncertainty. We are completely lacking in caselaw on the major changes to the legislation, and thus far there has been relatively little guidance from the European Data Protection Board (EDPB). BBMRI may cover the general ground, as might other suggestions for Charters etc. of international data sharing principles. But these will be a) novel in themselves b) not complete solutions and c) not targeted at in silico models for precision medicine. Concequently, our report will evaluate the impact of European law (data protection, research ethics- and regulation and patients’ rights ) as well as existing general standardization strategies specifically in the context of in silico modelling approaches for personalized medicine. We will explore this thoroughly based on input from the other WP’s and the ongoing H2020 research projects of EU-STANDS4PM.
Recommendations for legally and ethically sustainable transnational data harmonization, integration and in-silico models in personalized medicineThis report will describe final recommendations for the legally and ethically sustainable handling of data harmonization and integration for predictive in silioc models in personalized medicine A key component will focus on the suitability of various consent models including dynamic consent DC and the soulutions outlined in WP4 harmonized Data Access Agreements hDAA Registered Access RA and cloudbased access CbA These recommendations will reflect on transnational collaborative reserch projects regarding specific ethical and legal concerns and outline possible responses to such concerns based on collaboration with the other WPs the EUSTANDS4PM H2020 core projects and feedback from stakeholder consultation events Milestone 3
A user-friendly website with updated project information will be generated for use for scientific and non-scientific public and ready in M3. For further dissemination purposes print material (Flyer/brochure) [M6] and a video clip [M12] will be prepared.
External stakeholder boardTo address the representativeness of the European heterogeneity in terms of health systems, data governance, and regulatory issues we will aim at implementing an external cross-disciplinary advisory board in particular stakeholders representing the medical community at large as well as end users such as hospitals or clinical research organizations, patient representatives and/or industrial associations. The implementation of this board will start with the beginning of the project and will have a first focus on the engagement of the external projects and stakeholders listed in table 2 of Annex 1 representing the necessary breadth. Consequently the EU-wide representation will be balanced due to their country-wide composition as well. In addition, the direct interaction of the different EU-STANDS4PM partners with these projects/stakeholders will minimize the risk of low mobilization and engagement.
Pilot on harmonized data access agreement (hDAA)A harmonised data access agreement (hDAA) will be developed and implemented starting with the DAAs currently in use by the participating H2020 projects.The proposed workflow for the hDAA pilot contains the following stages:1) Review of core H2020 projects regarding DAAs currently in use2) Assessment in collaboration with WP1 (data sources and standards) and WP3 (consent and ethics) of each DAA clause if appropriate for inclusion in a DAA3) Drafting of a hDAA and circulation among European Data Access Committee (DAC) chairs for reviwe and further commentation4) Workshop for European DAC chairs and other relevant stakeholders to discuss hDAAs and identify additional barriers and agree on shared recommendations (MS4)5) Revision of the EU-STANDS4PM hDAA and issueing to the participating H2020 projects and corresponding DACs for testing and implementation6) Any feedback from this process will be collated and integrated into our final report and recommendations to the EC--- --- ---Changes in relation to the project extension:Approximately at month 36 we will provide an updated version (v2) of the hDAA that will be uploaded to the EGA website. This new version will conain changes in relation to the legal and ethical review provided by WP3 as well as changes in relation to the ongoing discussion with potential users of the hDAA.--- --- ---
Pilot to enrole up to five current H2020 projects into registered access (RA)The implementation of Registered Access (RA) will be envisaged as well as the enrolment of the core H2020 projects into RA. The proposed pilot will build on the experiences made in WP1, 2 and guided by WP3 that provides legal and ethical guidance. This RA pilot will follow the current three stage model of GA4GH that is based on 1) Authentification (potential data users meet specific requirements) 2) Attestation (terms of data use to which registered users must agree) 3) Authorization (technical processes through which a user will receive data access)
A project office will be put in place for the overall administrative management at the coordinators location. This office will support the project and the management bodies in secretarial tasks (templates, timetables, tracing the deadlines, collecting the deliverables, communication with the EU-Commission, moderation and conflict management).
Reports on awareness series workshops with focus on funding organizations, patient organizations, regulatory agencies, and collaborative projectsThese reports will describe the content and outcome of the awareness series workshops with focus on specific stakeholder communities such as funding organizations patient organizations regulatory agencies and collaborative projects The corresponding reports will be delivered in M12 M24 and M34
"WP2 aims at initiating the procedure to develop a formal standard document (ISO Technical Report: Requirements for in silico-models for personalized medicine –validating predictive computational models in EU collaborative research) for health data integration for predictive in silico models in personalized medicine (based on the output of WP1, 2). To start this process we will team up with existing formal (DIN/CEN/ISO) working groups and build upon the existing stable international communities. Especially with regard to in silico models in personalized medicine we will bridge between the scientific bottom up initiatives such as Clinical Data Interchange Standards Consortium (CDISC), the Global Alliance for Genomics and Health (GA4GH), the Proteomics Standards Initiative (PSI) of the Human Proteome Organization (HUPO), the Metabolomics Standards Initiative (MSI), the Computational Modelling in Biology Network (COMBINE). In a first step we will analyse and evaluate existing standards with regard to the following criteria: 1.Utilization of already existing standards 2.Modification of existing standards to fit our proposed aims 3.Detection of gaps where no standard is available so farIn a subsequent and focused workshop (related to MS2) the responsible EU-STANDS4PM forum members will evaluate the mapping process. The result of this work shop will be fixed in a report (in collaboration with all WPs) including which standards shall be used (without modification), which standards shall be used with modifications and were gaps of standards were found.For standards were modifications will be necessary, this modifications will be described, then the responsible CEN or ISO technical committee will be contacted to initiate the revision of the existing standard. Some aspects as the interoperability of data could be initiated at already existing committees (e. g. CEN/TC 251/WG 2 ""Technology and Applications"" or ISO/TC 215/WG 2 ""Systems and Device Interoperability""). Only for new aspects like in silico models a new working group might be established. If a need for such a new standard has been detected, the scope and the main requirements will be described by the responsible EU-STANDS4PM forum members (WP1 through 4). Using the network of beneficiary DIN a “new work item proposal” will be presented in the responsible working group to start ISO and/or CEN work items. This new work item proposal (https://www.iso.org/iso-forms-model-agendas-standard-letters.html) contains the following items:-responsible TC and Working Group,-title for the standard,-scope of this standard,-purpose and justification of the proposal -outline or first draft of the standard-type of standard (International and/or European Standard, Technical Specification or Technical Report)-project leader This new work item proposal will be given to the responsible CEN or ISO Technical committee (TC) to develop a new standard. This request will be circulated within the TC and if the members of the CEN or ISO agree the proposal, a working group of this TC will start to develop the proposed standard.--- --- ---Changes in relation to theproject extension:The ISO-Technical Report will be prepared and submitted to the ISO Technical Committee 276 Biotechnology/Working Group 5 (ISO/TC 276/WG 5), for which EU-STANDS4PM holds an official liaison. The document will specify requirements for data to be used for in silico or computational models (provided by WP1) and provides an overview of such models that can be considered for personalized medicine as best practice.--- --- ---"
The Project-Data Management Plan will outline how the project will produce and handle its WP-specific outputs and how this output will be made accessible. Focus is on WPs 1-4 and their objectives with regard to standardisation guidelines, recommendations and harmonization efforts. In addition the Project-Data Management Plan will contain information on relevant changes with regard to the consortium composition as well as its technical or scientific orientation that will be updated accordingly.
Publications
Author(s):
Catherine Bjerre Collin, Tom Gebhardt, Martin Golebiewski, Tugce Karaderi, Maximilian Hillemanns,
Faiz Muhammad Khan, Ali Salehzadeh-Yazdi, Marc Kirschner, Sylvia Krobitsch, EU-STANDS4PM consortium and Lars Kuepfer
Published in:
Journal of Personalized Medicine, 2022, ISSN 2075-4426
Publisher:
MDPI
DOI:
10.3390/jpm12020166
Author(s):
Miranda Mourby, Katharina ÓCathaoir, Catherine Bjerre Collin
Published in:
Computer Law & Security Review, 2021, ISSN 0267-3649
Publisher:
Pergamon Press Ltd.
DOI:
10.1016/j.clsr.2021.105611
Author(s):
Miranda Jane Mourby
Published in:
International Journal of Population Data Science, 2021, ISSN 2399-4908
Publisher:
IJPDS
DOI:
10.23889/ijpds.v5i4.1402
Author(s):
Søren Brunak, Catherine Bjerre Collin, EU-STANDS4PM consortium, Katharina Eva Ó Cathaoir, Martin Golebiewski, Marc Kirschner, Ingrid Kockum, Heike Moser, Dagmar Waltemath
Published in:
Journal of Integrative Bioinformatics, 2020, ISSN 1613-4516
Publisher:
Informationsmanagement in der Biotechnologie e.V. (IMBio e.V.)
Author(s):
Gefenas, E.
Lekstutiene, J.
Lukaseviciene, V.
Hartlev, M.
Mourby, M.
Cathaoir, K. O.
Published in:
Med Health Care Philos, 2021, ISSN 1572-8633
Publisher:
Springer
DOI:
10.1007/s11019-021-10060-1
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