Table Of Content. EUROPEAN REFERENCE NETWORK ON HEREDITARY METABOLIC DISEASES... 3 Summary... 4 Work Package... 5
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1 Table Of Content EUROPEAN REFERENCE NETWORK ON HEREDITARY METABOLIC DISEASES... 3 Summary... 4 Work Package... 5 Coordination and management... 5 Dissemination... 5 Evaluation... 5 Guidelines, Care Pathways and Standardization for Medical Care and Transition... 5 Virtual Counselling Framework... 5 Research, Translational Activities and Clinical Trials... 5 Capacity building and training... 5 Continuity of Care... 5 Coordinator, Leader contact and partners... 8 Outputs... 9 Publish monthly MetabERN Newsletter Publication of patient newsletters... 9 Strategy on overlapping diseases... 9 Strategy to define best practice in overlapping diseases by sharing vision with the ERN Coordinators by participating in regular meetings of ERN CG... 9 Content for website... 9 Management of social media channels... 9 Publication in journals/ media... 9 Publication on access to care for metabolic diseases across Europe... 9 Publication in relevant peer reviewed medical journals Implementation of patient-oriented section of MetabERN Website... 9 Evaluation of progress reports and reporting to Advisory Board and Coordinator... 9 Delphi consultation with stakeholders including industry, ethicists and regulators... 9 Analysis report from previously obtained MetabERN commitment forms... 9 Implementation of HCP survey on needs and expectations Semi-structured phone interviews and online surveys Empirical research on patient needs through questionnaires/ focus groups... 9 Overview on transitional requirements in IEM... 9 Consent of workflow for setting up GL/CP and documentation... 9 Standardized tool for disease-specific key parameters... 9 To develop data collection guidelines... 9 Identifying relevant grants programmes and active participation in EJP-RD... 9 Roll out of pilot project for delivery of therapeutics across the blood brain barrier... 9 Implementing surveys to collect information on distribution, quality, kind & results of on-going clinical trials... 9 Survey on patient education programmes in collaboration with POs... 9 Design and organisation of teaching and training programmes... 9 Survey on HCP education programmes and organisation of multidisciplinary consultations/ discussions on clinical cases... 9 Mapping of current teaching and learning programmes... 9 Wider dissemination of best practice programmes... 9 Setting up of training/ exchange programme between MetabERN centres and countries currently not represented... 9 Page 1/16
2 List of diagnostic technologies and services certified in each laboratory... 9 List of genome-wide genetic investigations in each laboratory... 9 Page 2/16
3 EUROPEAN REFERENCE NETWORK ON HEREDITARY METABOLIC DISEASES JA GPSD [705038] START DATE: 01/03/2018 END DATE: 28/02/2019 DURATION: 12 month(s) CURRENT STATUS: Finalised PROGRAMME TITLE: 3rd Health Programme ( ) PROGRAMME PRIORITY: - CALL: EUROPEAN REFERENCE NETWORKS SPECIFIC GRANT AGREEMENTS COVERING YEAR 2018 TOPIC: ERN Specific Grant Agreements Year 2 EC CONTRIBUTION: EUR KEYWORDS: Ern, Metabolic Diseases, Rare Disease Page 3/16
4 SUMMARY Project abstract The MetabERN is the first pan-european pan-metabolic network formed by 69 HCPs in 18 EU countries taking care, by now, of about patients and coupling the efforts of over 1700 multidisciplinary professionals. It aims to facilitate access to the best available care and address the needs across the border of all patients affected by rare inherited metabolic diseases and their families. The MetabERN is driven by the principle of patient-centeredness for the provision of its services aiming at improving the quality of life of patients and families independently from their kind and severity of any of the 700 described metabolic disorders. Patients Organisation (POs) play a crucial role into the planning and decision-making system related to patient care and management as well as policy activities impacting on the EU Rare Disease Policy Agenda. During the first year the MetabERN has been structured and organized. 7 Subnetworks of homogeneous diseases were created and 8 WPs for common activities rangings from prevention to clinical trials. Furthermore, a first patients is under discussion using the Clinical Patient Management Systems Platform (CPMS) provided by the EC. In line with the objectives and services defined in the FPA proposal, the second-year plan of activities of MetabERN focuses on: a) the optimisation of the clinical potential of MetabERN by the use of the Clinical Patient Management System Platform (CPMS); b) initiation of research activities in the metabolic field and identification of relevant partners for the development and implementation of these activities; c) the roll out of a development matrix and evaluation tools for guidelines and clinical pathways; d) the mapping of training needs for both patients and professionals in preparation of teaching and education programmes within the network in later years; e) the continued and targeted dissemination of information about the network to increase awareness in the relevant communities. Page 4/16
5 Work package Work Package 1: Coordination and management Start month: 1 End month: 12 Work Package Leader: The aim will be achieved through continuous monitoring of the progress of both Work Packages and Subnetworks, including the preparation of bi-monthly reports that will feed into the annual report. The organisation of Board meetings involving all stakeholders will be crucial to ensure regular information exchange. Moreover, the WPs will focus on creating synergies with other ERNs in order to be able to tap into existing expertise for the benefit of patients. Meetings with other ERNs/RD Connect/EC will be crucial for sharing knowledge and best practices and identifying common strategies to avoid duplication of efforts and to harmonise and integrate expertise and impact of EU rare diseases policy. External subcontractors will be identified to support the management of the Advisory Board and the organisation of the Board Meeting. Work Package 2: Dissemination Start month: 1 End month: 12 Work Package Leader: WP2 will implement a series of dissemination activities (presentations at conferences, published papers, patient support group education and conferences, newsletters, videos, educational web presentations, social media channels and website). A dissemination plan defining strategies, processes and tools to promote the projects and its output will be developed. Patient involvement in all dissemination and awareness activities will be ensured. The WP will also ensure continuous liaison with EU policy makers and relevant stakeholders, for example through the organisation of a meeting in the European Parliament that will inform policy makers about the needs of patients with IMDs. To ensure that the materials prepared for the Parliamentary launch of the project are appropriate and suitable for a policy audience, the preparation and organisation of the event will be subcontracted to a third party with proven experience in rare disease policy. A retainer contract will also be granted to a third party for the maintenance of the website and social media channels. Work Package 3: Evaluation Start month: 1 End month: 12 Page 5/16
6 Work Package Leader: WP3 will ensure transparency on possible conflicts of interest and the official adoption of a Conflict of Interest policy. The WP will develop a survey to assess the needs of HCPs and to develop criteria for the evaluation of professional-centred needs for MetabERN services. Surveys will be also used to monitor the satisfaction of HCPs with MetabERN activities in daily clinical practice. Similarly, patient needs and expectations about activities will be identified and specific criteria for the evaluation of the patient-centeredness of services will be developed. Work Package 4: Guidelines, Care Pathways and Standardization for Medical Care and Transition Start month: 1 End month: 12 Work Package Leader: WP 4 will focus on the development of transition guidelines and unmet needs in this area. A consensus statement will contain an overview on transitional requirements in IEM. The WP will also define and prepare a first pilot project for Guidelines/Care Pathways, starting with consensus on the workflow that has been set up for GL/CP documentation. A standardized tool for disease-specific key parameters will be developed in order to be able to evaluate the implementation and impact of GL/CP on disease outcome. Defining measurable disease-parameters will facilitate i) the evaluation of clinical practice, ii) documentation of the natural course of the disease and thus knowledge and treatment options/efficacy. Consultations with all WP and Subnetwork leaders as well as with European and national scientific societies will take place before implementing the final tool. Work Package 5: Virtual Counselling Framework Start month: 1 End month: 12 Work Package Leader: WP5 will focus on promoting, implementing and developing the use of the CPMS within the network. Guidelines for the use of the system need to be developed and the system needs to be used on a regular basis by all HCPs in order to improve its use. Continued input and support from the IT Helpdesk is expected. Furthermore, this WP will focus on using the CPMS to develop guidelines for data and DNA sampling collection. Work Package 6: Research, Translational Activities and Page 6/16
7 Clinical Trials Start month: 1 End month: 12 Work Package Leader: WP6 will identify potential project grant sources to initiate research projects and forge partnerships, including through active participation in the EJP-RD Programme. The WP has a particular interest in generating projects devoted to the development of blood brain barrier crossing therapies for effective delivery of therapeutic molecules to the brain. Surveys will serve to collect information on the state of the art of development of innovative therapies. The results will feed into a detailed report and recommendations on the priority setting for the research agenda in the area of IMDs and will be used for the generation of a white book on the situation of clinical trials on IMDs. Work Package 7: Capacity building and training Start month: 1 End month: 12 Work Package Leader: WP7 will develop a survey on patient education programmes in close collaboration with patient organisations in order to get a clear understanding of the needs of IMD patients and to ultimately design and organise teaching and training programmes, particularly in countries where currently no such programmes exist. The same will be done for HCP education programmes. The CPMS will be used to organise multidisciplinary consultations and discussions of clinical cases. To achieve a better idea of what programmes currently exist, a mapping exercise will be undertaken. Once in place, the best practice programmes will be widely disseminated. Work Package 8: Continuity of Care Start month: 1 End month: 12 Work Package Leader: In order to have access to the best diagnostics (biochemical/genetic) and to genome-wide genetic investigations for undiagnosed patients with complex disorders, a list of diagnostic technologies and services certified in laboratories will be drawn up. Page 7/16
8 COORDINATOR, LEADER CONTACT AND PARTNERS COORDINATOR HSK DR HORST SCHMIDT-KLINIKEN GMBHKLINIKUM DER LANDESHAUPSTADT WIESBADEN (HSK) LUDWIG ERHARD STRASSE WIESBADEN Germany PARTNERS No partners related to the current project Page 8/16
9 OUTPUTS Publish monthly MetabERN Newsletter Expected on: 01/03/2019 Provide information on current and upcoming activities of the network 1 Publication of patient newsletters Expected on: 01/07/2018 Publish newsletter with information aimed at and with input from the patients Strategy on overlapping diseases Expected on: 01/06/2018 Development of strategy on how to deal with overlapping diseases Strategy to define best practice in overlapping diseases by sharing vision with the ERN Coordinators by participating in regular meetings of ERN CG Expected on: 01/03/2019 Development of strategy for best practice with overlapping diseases Content for website Page 9/16
10 Expected on: 01/03/2019 Content management of website: Carry out continuous updates of the website Management of social media channels Expected on: 01/03/2019 Place regular and updated content in different social media channels Publication in journals/ media Expected on: 01/07/2018 Publish articles in scientific peer-reviewed journals or in equivalent media to disseminate research work completed within network on rare metabolic diseases Publication on access to care for metabolic diseases across Europe Expected on: 01/07/2018 Publish white paper/article on access to care. Publication in relevant peer reviewed medical journals Expected on: 01/01/2019 Publication in relevant peer reviewed medical journals Page 10/16
11 2.6.2 Implementation of patient-oriented section of MetabERN Website Expected on: 01/06/2018 Publication and continuous development of a dedicated patient section on website Evaluation of progress reports and reporting to Advisory Board and Coordinator Expected on: 01/09/2018 Compare achievements in progress reports of each WP to pre-set goals Send a detailed report to the Advisory Board and Coordinator on progress made Delphi consultation with stakeholders including industry, ethicists and regulators Expected on: 01/09/2018 Delphi consultation on Conflict of Interest with stakeholders, incl. industry, ethicists and regulators and publication of report on CoI Analysis report from previously obtained MetabERN commitment forms Expected on: 01/05/2018 Establish needs expressed at the inception of the network and develop a short report Page 11/16
12 Implementation of HCP survey on needs and expectations Expected on: 01/09/2018 Identify the major needs and expectations of HCPs through the roll out of a survey within the group of MetabERN HCPs Semi-structured phone interviews and online surveys Expected on: 01/01/2019 Completion of phone interviews and online surveys with HCPs and preparation of short report around expectations, impact and outcomes of the network s activities for daily clinical practice Empirical research on patient needs through questionnaires/ focus groups Expected on: 01/01/2019 Development and publication of both questionnaires and targeted focus groups Publication of results and key findings Overview on transitional requirements in IEM Expected on: 01/03/2019 Develop a document presenting an overview of the transitional requirements in IEM Page 12/16
13 Consent of workflow for setting up GL/CP and documentation Expected on: 01/06/2018 Publishing consent document on the workflow for setting up GL/CP and accompanying documentation Standardized tool for disease-specific key parameters Expected on: 01/01/2019 Develop a standardised tool to establish disease-specific key parameters To develop data collection guidelines Expected on: 01/07/2018 Development of guidelines and a helpdesk service to facilitate the CPMS use and guidelines for data and DNA sampling collection Identifying relevant grants programmes and active participation in EJP-RD Expected on: 01/06/2018 Collate a list of available grant options and fundraising possibilities Draw up a calendar of deadlines for the identified grants/projects Identify opportunities to actively participate in the EJP RD Roll out of pilot project for delivery of Page 13/16
14 therapeutics across the blood brain barrier Expected on: 01/03/2019 Disseminate the pilot project in designated MetabERN member states Implementing surveys to collect information on distribution, quality, kind & results of on-going clinical trials Expected on: 01/03/2019 Survey to collect information about distribution, quality, kind and results of ongoing clinical trials and development of subsequent report Survey on patient education programmes in collaboration with POs Expected on: 01/06/2018 Survey on patient education programmes within the group of collaborating patient organisations in the MetabERN and subsequent short report with key findings and conclusions Design and organisation of teaching and training programmes Expected on: 01/02/2019 Develop teaching and training programmes that are set up and ready to use by members and partners of the network Page 14/16
15 Survey on HCP education programmes and organisation of multidisciplinary consultations/ discussions on clinical cases Expected on: 01/06/2018 Survey on HCP education programmes within the group of collaborating healthcare providers in the MetabERN and subsequent short report with key findings and conclusions Mapping of current teaching and learning programmes Expected on: 01/06/2018 Develop a mapping document outlining current teaching and learning opportunities Wider dissemination of best practice programmes Expected on: 01/12/2018 Set up a strategy for the wider dissemination of best practice programmes Setting up of training/ exchange programme between MetabERN centres and countries currently not represented Expected on: 01/02/2019 Design, develop and organise training/exchange programmes targeting centres in countries that are currently not represented within the network Page 15/16
16 Powered by TCPDF ( List of diagnostic technologies and services certified in each laboratory Expected on: 01/12/2018 Collation and dissemination of diagnostic technologies list List of genome-wide genetic investigations in each laboratory Expected on: 01/01/2019 Collation and dissemination of a list of whole exome and genome sequence providers in Europe and establishment of access Page 16/16
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