Practical experience in implementing surveillance of antiviral resistance in several European countries in accordance with personal data regulation
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1 Practical experience in implementing surveillance of antiviral resistance in several European countries in accordance with personal data regulation Katja Deterding Medizinische Hochschule Hannover
2 Antiviral drug resistance: Viral Hepatitis Hepatitis B (PEG-) Interferon alpha Nucleos(t)ides Combination therapies Hepatitis C PEG-Interferon alpha + Ribavirin New antivirals ( Enzyme inhibitors, etc. )
3 VIRGIL European Network of Excellence integrating the expertise of national networks + ISRAEL
4 VIRGIL Network Composition 12 European member states 55 Institutions Steering committee 60 Project Management Scientific Teams Governing Board Scientific Advisory Board Patients Advocacy Groups 7 Companies Bioalliance BioMérieux LiverDoc Retroscreen Riotech Tripep
5 VIRGIL - Platforms
6 VIRGIL Surveillance Platform PARTNERS IN HEPATITIS SURVEILLANCE Medizinische Hochschule Hannover Medizinische Hochschule Hannover (Germany) (Germany) Michael Manns Michael Manns Ludwig Maximilians Universität Ludwig Maximilians Universität München (Germany) München (Germany) T Mueller T Mueller AIES-Hospital Carlos III AIES-Hospital Carlos III (Italy) (Italy) V Soriano V Soriano Hospital Clínic Provincial de Hospital Clínic Provincial de Barcelona (Spain) Barcelona (Spain) X Forns X Forns Inserm (France) Inserm (France) C Trepo / F Zoulim C Trepo / F Zoulim C Brechot C Brechot The University of Birmingham The University of Birmingham (UK) (UK) D Mutimer D Mutimer University of Gdansk Faculty University of Gdansk Faculty of Biotechnology (Poland) A of Biotechnology (Poland) A Podhajska Podhajska Papageorgious General Papageorgious General Hospital (Greece) Hospital (Greece) G Germanidis G Germanidis Azienda Ospedaliera di Parma Azienda Ospedaliera di Parma (Italy) (Italy) C Ferrari C Ferrari Hospital Universitario Valle Hospital Universitario Valle Hebron (Spain) Hebron (Spain) R Esteban Mur / M Buti R Esteban Mur / M Buti Karolinska Institutet Karolinska Institutet (Sweden) (Sweden) O Weiland / M Sällberg O Weiland / M Sällberg Université Catholique de Université Catholique de Louvain (Belgium) Louvain (Belgium) E Sokal E Sokal Université Paris XII-Val-de- Université Paris XII-Val-de- Marne (France) Marne (France) JM Pawlotsky JM Pawlotsky Tripep AB Tripep AB (Sweden) (Sweden) A Vahlne A Vahlne Charité Campus Virchow-Klinikum Charité Campus Virchow-Klinikum Uni Berlin (Ger) Uni Berlin (Ger) T Berg T Berg Imperial College of Science (UK) Imperial College of Science (UK) H Thomas H Thomas University of Bari University of Bari (Italy) (Italy) G Pastore / T Santantonio G Pastore / T Santantonio Université de Genève Université de Genève (Swizterland) (Swizterland) F Negro F Negro Universität des Saarlandes Universität des Saarlandes (Germany) (Germany) S Zeuzem S Zeuzem Venetian Institute of Molecular Venetian Institute of Molecular Medicine (Italy) A Alberti Medicine (Italy) A Alberti
7 Integration of local existing networks EISS Virgil-Flu Virgil-Hepatitis UK MRC cooperative Infectious Disease network Sweden Local cohorts Stockholm Hep-Net Germany Italy Local network north East Italy France ANRS Local cohorts Lyon, Paris Spain Local cohorts Madrid, Barcelona Switzerland Swiss Hepatitis Network Netherlands Local cohorts
8 Main Aims of the SURVEILLANCE Network Minimise emergence and spread of antiviral drug resistance in cooperation with the other platforms Quality control European IT- platform Research of special patient groups SURVEIL Central serum bank Information on the prevalence and spread of viral resistant strains in Europe European online database for the documentation of patients with antiviral drug resistance
9 VIRGIL - Online Database
10 European database 1. Central Database for Europe and comprehensive IT- platform 2. Serum samples Basis for other projects,, e.g. investigation of viral and host mechanisms of drug resistance
11 VIRGIL - Online Database Data about treatment failures Information flow backwards about resistance testing WEB-DATABASE Clinvir-Platform [complete testing only in cases with highly probable resistance] Surveil centers in EU Models Host Innotech
12 Case report forms online documentation 1. Standard documentation 2. Primary documentation 3. Documentation of the clinical course 4. End of documentation
13 Cooperation Surveil /Clinvir - interim solution - Local Sites Report CRFs Surveil Central Sequence Data Serum Samples Clinvir Central
14 Patient informed consent form - available in 9 different languages English German French Italian Spanish Dutch Swedish Greek Polish Türkish Russian
15
16 VIRGIL - Online Database Positive Votum from the ethics committee Hannover
17 VIRGIL - Online Database The following documents were sent to all Virgil Surveillance partners and all additional clinicans within the Virgil Network Study protocoll Patient informed consent forms Positive votum from the ethics committee Hannover Case report forms all partners were ask to get in contact with their own ethics committee
18 Problems in different countries: Insurance Different patient groups e.g. children
19 Virgil online database: Two ways of documentation 1. Patients who have signed the informed consent form before or at the date of data entry should be entered as pseudonymised/ identifiable patients (documentation with patient initials) 2. Patients who have not signed the informed consent form before or at the date of data entry should be entered as anonymised patients. (documentation without patient initials)
20 VIRGIL - Online Database Every Hepatitis B (D) and Hepatitis C patient with ongoing or previous antiviral treatment should be entered in the Virgil online database Every Virgil partner will receive a user name and a password to link via internet to the database It must be documented at each center wich patient belongs to which patient number!!!
21 VIRGIL - Online Database 1. Standard Documentation
22 2. Primary Documentation
23 3. Follow-up
24 Serum samples Every serum sample should be registered in the database before shipment Enter the clinical data Click on: SERUM SAMPLES WILL BE SEND You will receive a sample-id, wich should be written on the tube before shipment The link between patient-id (clinical data) and serum-id (analysis) is only possible for the IT-Platform (Thomas Müller)
25 Summary Different legal issues in the european countries, especially for the shipment of serum samples Different patient groups, e.g. children Different regulations concering the patient insurance Differentiation between anonymised and pseudonymised documentation In some european countries is one central ethics votum not sufficient
26
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