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Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 17.89M | Year: 2011

Medicine is undergoing a revolution that is transforming the nature of healthcare from reactive to preventive. The changes are catalyzed by a new systems approach to disease which focuses on integrated diagnosis, treatment and prevention of disease in individuals. This will replace our current mode of medicine over the coming years with a personalized predictive treatment . While the goal is clear, the path is fraught with challenges.P-medicine brings together international leaders in their fields to create an infrastructure that will facilitate this translation from current practice to personalized medicine. In achieving this objective p-medicine has formulated a coherent, integrated workplan for the design, development, integration and validation of technologically challenging areas of today.Our emphasis is on formulating an open, modular framework of tools and services, so that p-medicine can be adopted gradually, including efficient secure sharing and handling of large personalized data sets, enabling demanding Virtual Physiological Human (VPH) multiscale simulations (in silico oncology), building standards-compliant tools and models for VPH research, drawing on the VPH Toolkit and providing tools for large-scale, privacy-preserving data and literature mining, a key component of VPH research. We will ensure that privacy, non-discrimination, and access policies are aligned to maximize protection of and benefit to patients. The p-medicine tools and technologies will be validated within the concrete setting of advanced clinical research. Pilot cancer trials have been selected based on clear research objectives, emphasising the need to integrate multilevel datasets, in the domains of Wilms tumour, breast cancer and leukaemia. To sustain a self-supporting infrastructure realistic use cases will be built that will demonstrate tangible results for clinicians.The project is clinically driven and promotes the principle of open source and open standards.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 5.68M | Year: 2011

There is a strong need in biomedical research, especially in the case of complex heterogeneous diseases such as cancer, to achieve an all-comprising harmonization of efforts: To integrate the available data and knowledge in comprehensive models supported by interoperable infrastructures and tools, to standardize methodologies, and to achieve wide-scale data sharing and reuse, and multidisciplinary collaboration. INTEGRATE aims to build solutions that support a large and multidisciplinary biomedical community ranging from basic, translational and clinical researchers to the pharmaceutical industry to collaborate, share data and knowledge, and build and share predictive models for response to therapies, with the end goal of improving patient outcome. Moving away from empirical medicine, towards evidence-based personalized care has the potential to both dramatically improve patient outcome and to reduce costs. INTEGRATE will deliver reconfigurable infrastructure components; tools for sharing and collaboration; standards-based data models; and repositories of data, models and knowledge. The INTEGRATE environment will enable: Collection, preservation, management and reuse of data collected within multi-centric clinical trials. These unique comprehensive datasets will be made available through uniform interfaces to support information sharing and collaborative knowledge generation. Multi-disciplinary collaboration, providing an environment and tools that support researchers across domains, institutions and industries to jointly contribute to research objectives, develop common methodologies and complex analyses, and efficiently make use of each others expertise and results. Collaborative definition and development of relevant clinical questions and more efficient validation of potential biomarker results and predictive models in clinical trials. Collaborative development, preservation and sharing of multi-scale realistic and validated predictive models of response to novel therapies and anti-cancer drugs. We will propose methodologies for model development, a modelling framework, and predictive multi-scale models in the context of breast cancer. INTEGRATE will also provide standards-based interoperability to existing research and clinical infrastructures to support efficient information reuse and integration.

Agency: Cordis | Branch: FP7 | Program: CSA-SA | Phase: HEALTH.2010.4.2-6 | Award Amount: 581.79K | Year: 2010

CONTRACT is about consent. The project focuses on analysing how the legal (and underlying ethical) concepts of informed consent in the European Data Protection Directive and in the Clinical Trials Directive have had and continue to have an impact on the success of translational research. The project predominantly deals with vulnerable patients as their consent is of utmost complexity. The concept of informed consent in the two mentioned Directives will be analysed from a legal, ethical, IT-related and clinical point of view. The European approach on the matter will be compared with national concepts of informed consent for care purposes in the Member States. CONTRACT will support the European Commission and other policymakers in achieving a clear Community framework by providing clarity on different concepts of informed consent on European and national level. CONTRACTs approach will be based on facts and figures by delivering an empirical survey about the handling of consent in European and national translational trials. CONTRACT will identify good practices in obtaining and administering informed consent in translational research and will give recommendations on possible harmonization of and common approaches to the legal framework. CONTRACT has already built a target community for its services, the partner projects, which will be significantly enlarged after the projects start. CONTRACT will offer a help desk for its target audience on consent issues and will constantly support partner projects and other relevant stakeholders in balancing patients and research interests by a proper management of consent. In achieving these objectives the project has put together an internationally recognised interdisciplinary team of individuals and organisations with significant expertise and know-how on all areas of relevance to the project, it has drawn-up a ambitious yet achievable - workplan, and has made every effort to identify and minimize potential risks.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2011.5.2 | Award Amount: 13.91M | Year: 2013

Developing robust, reproducible, interoperable and collaborative hyper-models of diseases and normal physiology is a sine qua non necessity if rational, coherent and comprehensive exploitation of the invaluable information hidden within human multiscale biological data is envisaged. Responding to this imperative in the context of both the broad Virtual Physiological Human (VPH) initiative and the paradigmatic cancer domain, CHIC proposes the development of a suite of tools, services and secure infrastructure that will support accessibility and reusability of VPH mathematical and computational hypermodels. These will include a hypermodelling infrastructure consisting primarily of a hypermodelling editor and a hypermodelling execution environment, an infrastructure for semantic metadata management, a hypermodel repository, a hypermodel-driven clinical data repository, a distributed metadata repository and an in silico trial repository for the storage of executed simulation scenarios. Multiscale models and data will be semantically annotated using the ontological and annotating tools to be developed. An image processing and visualization toolkit, and cloud and virtualization services will also be developed. The CHIC tools, services, infrastructure and repositories will provide the community with a collaborative interface for exchanging knowledge and sharing work in an effective and standardized way. A number of open source features and tools will enhance usability and accessibility. In order to ensure clinical relevance and foster clinical acceptance of hypermodelling in the future, the whole endeavour will be driven by the clinical partners of the consortium. Cancer hypermodels to be collaboratively developed by the consortium cancer modellers will provide the framework and the testbed for the development of the CHIC technologies. Clinical adaptation and partial clinical validation of hypermodels and hypermodel oncosimulators will be undertaken.

Agency: Cordis | Branch: FP7 | Program: CSA | Phase: ICT-2007.5.3 | Award Amount: 1.25M | Year: 2008

RADICAL coordination action aims at approaching coherently, studying in depth and revealing scientifically, the beyond the state-of the art research and policy roadmap for security and privacy enhancement in Virtual Physiological Human, taking into consideration technology advancements, business and societal needs, ethics and challenges that should be addressed and answered. RADICAL objectives are: Benchmarking existing security and privacy technologies. There will be a special focus on Privacy Enhancing Technologies, which assist in designing information and communication systems and services in a way that minimizes the collection and use of personal data and facilitate compliance with data protection rules. Identify the required technology developments and implementation challenges in order to define the gap between the present (as is situation) and the future desired status. Identify the societal needs and challenges that should be addressed in order to protect health patient records and regulate their usage. Analyze the implications of health data usage, with special focus to the genetic data usage. Capitalize on existing knowledge acquired by EC funded projects under 6th Framework, using their Provide a Policy Paper Roadmap for the Future Agenda in Medical and Genetic Data. Develop a Good Practice Guide, presenting the best practices that should be adopted by different stakeholders. Creating a network of stakeholders

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