EOSC-Life is a 4-year project funded under the European Union's Horizon 2020 programme. It aims to bring together the 13 Research Infrastructures in the Health and Food domain of the ESFRI Roadmap to create an open, collaborative digital space for life sciences in the European Open Science Cloud (EOSC). In March 2020, after the COVID-19 pandemic outbreak and as a rapid response to it EOSC-Life added to its work plan two new work packages to help tackle the pandemic. In EOSC-Life WP14, the European Clinical Research Infrastructure Network (ECRIN, https://ecrin.org/) has partnered with the University of Oslo (UiO, https://www.uio.no/english/) in order to commonly design, develop, implement and operate a repository for individual participant data (IPD) from COVID-19 clinical research studies that is compliant with European regulations and in particular with the GDPR. For the storage of the IPD, the TSD infrastructure of the University of Oslo will be used, which is a multitenant remote access system with a strong set of built-in security measures. The present document highlights the Data Sharing Policy of the COVID-19 repository under development in EOSC-Life WP14. A model Data Transfer Agreement for further discussions with Data Object Providers can also be made available on request (contact maria.panagiotopoulou@ecrin.org).
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans. ; (VLID)6184214
AbstractOpen Science is a founding principle of ELIXIR, a pan‐European research infrastructure for life science data, with 21 Member countries plus the European Molecular Biology Laboratory. The mission of ELIXIR is to coordinate bioinformatics resources so that they form a single, integrated and pan‐European infrastructure, which can be used freely by academic and private‐sector researchers across the globe. As a recipient of public and charitable funding, ELIXIR must demonstrate its value, and the need to produce evidence in support of this is intensifying. Our practice‐led journey towards demonstrating public value is articulated around five main challenges and, for each, we present our pragmatic approach for tackling it. We begin by showing how we are working towards demystifying what research infrastructures do. We then shed light on the sort of evidence our funders and other stakeholders are asking us for, how this evidence varies in nature and scope, and our tactics to satisfy them. We follow‐on by providing our thoughts on possible barriers and solutions to embedding impact evaluation in our activities. Finally, we provide lessons learned, which we believe are sufficiently transferable and will be inspirational to other research infrastructures as they embark on their own journeys to demonstrate public value.
ELIXIR's International Strategy describes current activities of international relevance, and planned implementation actions to reinforce ELIXIR's global significance and impact. An update is released on an annual basis. In the context of this document, the term 'International' means 'beyond Europe', with 'Europe' defined as the countries of the European Research Area1 (ERA). The Strategy is articulated around four main objectives: (1) scale-up the international user base of ELIXIR's Services, (2) improve bioinformatics services and promote global standards, (3) expand Membership in ELIXIR beyond Europe, and (4) ensure that ELIXIR is recognised as an infrastructure of global relevance, and a partner of choice by intergovernmental organisations. The international audience of the Strategy encompasses users of bioinformatics services, national-level bioinformatics infrastructures, and government officials in Ministries. Also targeted by this Strategy are international bioinformatics-related initiatives and organisations, and intergovernmental organisations. Closer to home, the Strategy aims to raise awareness of ELIXIR's global significance within Member countries, and guide efforts to ensure coherent implementation actions in support of the objectives of the Strategy. The strategy will be implemented through a concrete set of Actions, described in Annex I, each relating to one of the four specific Objectives.
eTRANSAFE is a research project funded within the Innovative Medicines Initiative (IMI), which aims at developing integrated databases and computational tools (the eTRANSAFE ToxHub) that support the translational safety assessment of new drugs by using legacy data provided by the pharmaceutical companies that participate in the project. The project objectives include the development of databases containing preclinical and clinical data, computational systems for translational analysis including tools for data query, analysis and visualization, as well as computational models to explain and predict drug safety events. ; This research received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreements eTRANSAFE (777365). This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA companies in kind contribution. The Research Programme on Biomedical Informatics (GRIB) of IMIM and DCEXS-UPF is a member of the Spanish National Bioinformatics Institute (INB), PRB2-ISCIII and is supported by grant PT13/0001/0023, of the PE I + D + i 2013–2016, funded by ISCIII and FEDER. The GRIB also receive support from Agència de Gestió D'ajuts Universitaris i de Recerca Generalitat de Catalunya (AGAUR, ref.: 2017SGR01020). The DCEXS is a "Unidad de Excelencia María de Maeztu", funded by the MINECO (ref: MDM-2014-0370). ; Peer Reviewed ; Postprint (published version)
In: Auffray , C , Balling , R , Barroso , I , Bencze , L , Benson , M , Bergeron , J , Bernal-Delgado , E , Blomberg , N , Bock , C , Conesa , A , Del Signore , S , Delogne , C , Devilee , P , Di Meglio , A , Eijkemans , M , Flicek , P , Graf , N , Grimm , V , Guchelaar , H J , Guo , Y K , Gut , I G , Hanbury , A , Hanif , S , Hilgers , R D , Honrado , Á , Hose , D R , Houwing-Duistermaat , J , Hubbard , T , Janacek , S H , Karanikas , H , Kievits , T , Kohler , M , Kremer , A , Lanfear , J , Lengauer , T , Maes , E , Meert , T , Müller , W , Nickel , D , Oledzki , P , Pedersen , B , Petkovic , M , Pliakos , K , Rattray , M , i Màs , J R , Schneider , R , Sengstag , T , Serra-Picamal , X , Spek , W , Vaas , L A I , van Batenburg , O , Vandelaer , M , Varnai , P , Villoslada , P , Vizcaíno , J A , Wubbe , J P M & Zanetti , G 2016 , ' Making sense of big data in health research : Towards an EU action plan ' , Genome medicine , vol. 8 , no. 1 , 71 . https://doi.org/10.1186/s13073-016-0323-y
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.
In: Auffray , C , Balling , R , Barroso , I , Bencze , L , Benson , M , Bergeron , J , Bernal-Delgado , E , Blomberg , N , Bock , C , Conesa , A , Del Signore , S , Delogne , C , Devilee , P , Di Meglio , A , Eijkemans , M , Flicek , P , Graf , N , Grimm , V , Guchelaar , H-J , Guo , Y-K , Gut , I G , Hanbury , A , Hanif , S , Hilgers , R-D , Honrado , Á , Hose , D R , Houwing-Duistermaat , J , Hubbard , T , Janacek , S H , Karanikas , H , Kievits , T , Kohler , M , Kremer , A , Lanfear , J , Lengauer , T , Maes , E , Meert , T , Müller , W , Nickel , D , Oledzki , P , Pedersen , B , Petkovic , M , Pliakos , K , Rattray , M , I Màs , J R , Schneider , R , Sengstag , T , Serra-Picamal , X , Spek , W , Vaas , L A I , van Batenburg , O , Vandelaer , M , Varnai , P , Villoslada , P , Vizcaíno , J A , Wubbe , J P M & Zanetti , G 2016 , ' Making sense of big data in health research : Towards an EU action plan ' Genome Medicine , vol 8 , no. 1 , pp. 71 . DOI:10.1186/s13073-016-0323-y
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.
In: Auffray , C , Balling , R , Barroso , I , Bencze , L , Benson , M , Bergeron , J , Bernal-Delgado , E , Blomberg , N , Bock , C , Conesa , A , Del Signore , S , Delogne , C , Devilee , P , Di Meglio , A , Eijkemans , M , Flicek , P , Graf , N , Grimm , V , Guchelaar , H J , Guo , Y K , Gut , I G , Hanbury , A , Hanif , S , Hilgers , R D , Honrado , Á , Hose , D R , Houwing-Duistermaat , J , Hubbard , T , Janacek , S H , Karanikas , H , Kievits , T , Kohler , M , Kremer , A , Lanfear , J , Lengauer , T , Maes , E , Meert , T , Müller , W , Nickel , D , Oledzki , P , Pedersen , B , Petkovic , M , Pliakos , K , Rattray , M , i Màs , J R , Schneider , R , Sengstag , T , Serra-Picamal , X , Spek , W , Vaas , L A I , van Batenburg , O , Vandelaer , M , Varnai , P , Villoslada , P , Vizcaíno , J A , Wubbe , J P M & Zanetti , G 2016 , ' Erratum to : Making sense of big data in health research: Towards an EU action plan [Genome Med., 8 (2016) (71)] ' , Genome medicine , vol. 8 , no. 1 , 118 . https://doi.org/10.1186/s13073-016-0376-y
The published article [1] has two points of confusion in the section entitled "Technical challenges related to the management of electronic health records". Firstly, the International Rare Diseases Research Consortium (IRDiRC) has developed policies and guidelines on approaches to data sharing meant to enable and improve the development of diagnoses and therapies for rare diseases. However, at present, IRDiRC has not developed best practices for the management of electronic health records (EHRs). Secondly, RARE-Bestpractices is a European Commission 7th Framework Programme (FP7) funded initiative, independent of IRDiRC. RARE-Bestpractices contributes to IRDiRC goals and objectives; however the initiative itself is not sponsored nor connected to IRDiRC.
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health arid healthcare for all Europearis. ; Funding Agencies|European Union [115568, 603160, 282510, 664691, 115749, 305033, 305397, 288028, 242189, 211601]; European Molecular Biology Laboratory; Wellcome Trust [WT098051]; [115372]; [257082]; [291814]; [291728]; [321567]; [262055]; [115446]; [602552]; [644753]; [634143]; [261357]; [305280]; [115525]; [2011 23 02]; [270089]; [278433]; [602525]; [201418]; [242135]; [260558]; [223411]; [305626]; [115621]; [611388]; [306000]; [354457]; [305564]; [115010]; [269978]
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively. Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.