Annette Pollex-Krüger, Johannes Drepper, Sebastian C. Semler. Telematikplattform für Medizinische Forschungsnetze (TMF) e.v.
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1 TMF A Common Platform for Medical Research Networks in Germany Improving the Organisation and Infrastructure of Medical Research in Cooperative Structures ELN Workshop on Information Technology II Heidelberg, Annette Pollex-Krüger, Johannes Drepper, Sebastian C. Semler Telematikplattform für Medizinische Forschungsnetze (TMF) e.v. TMF-Office, Berlin Telematikplattform für Medizinische Forschungsnetze (TMF) e.v.
2 Outline Changes in framework conditions for clinical research Structure, programme and aims of TMF IT-Support for clinical trials From tools to infrastructure ELN IT-Workshop II, Seite 2
3 Changes in Framework Conditions Regulations for clinical research Complexity of demands and solutions Cost pressure Standardization in medical research and health care European and international research projects Public funding ELN IT-Workshop II, Seite 3
4 Changes in Framework Conditions Source: Origin and funding of the most frequently cited papers in medicine: database analysis. Patsopoulos, Analatos, Ioannidis. BMJ 2006 ELN IT-Workshop II, Seite 4
5 Outline Changes in framework conditions for clinical research Structure, programme and aims of TMF IT-Support for clinical trials From tools to infrastructure ELN IT-Workshop II, Seite 5
6 WhoisTMF? Organisation for Medical Research Networks in Germany Meta-organisation of the medical research associations Funded by the German Ministry of Education and Research (BMBF) Founded in 1999 parallel to the establishment of large scale collaboration projects in the German research fields: Competence networks in medicine (KN) Coordinating centres for clinical trials (KKS) ELN IT-Workshop II, Seite 6
7 Meta-organisation TMF Networked research: common demands and problems (technical, legal, organisational) central nation-wide acting partner for issues of networked medical research broad focus: technical platform and communication broker within the community one of the few national central institutions for telematics in health care in Germany ELN IT-Workshop II, Seite 7
8 Aims to improve medical research in terms of quality, organisation and cooperation to develop high-performance IT infrastructures, implementation in interconnected structures to solve common questions of networked medical research (e.g. collecting, processing and exchanging research data) to clarify the legal and ethical framework for conducting medical research to contribute to sustainable and efficient health research by improved translation of research findings into health care ELN IT-Workshop II, Seite 8
9 Members Members national networks and institutions Competence Networks in Medicine Coordinating Centres for Clinical Trials Networks for Rare Diseases German National Genome Research Network Fraunhofer Institute for Toxicology and experimental Medicine Academic Institutes Patient Organisations Zoonosis Research Networks and others 2007: ca 60 members (2003: 30 members) ELN IT-Workshop II, Seite 9
10 Structure ELN IT-Workshop II, Seite 10
11 Working groups IT infrastructure and Quality management Data protection, privacy and security Biobanks Management of clinical trials Molecular Medicine Forums 3 role-specific forums: Network speakers, CEOs, PR officers Rare Diseases Networks NEW: Forum Grid ELN IT-Workshop II, Seite 11
12 Main Topics of TMF Projects TMF Projects bottom-up approach scientist-defined needs and projects, funded by BMBF (via TMF) Main topics Legal and ethical framework conditions Quality management Interconnection of research and health care Standards and terminology IT infrastructure for clinical research ELN IT-Workshop II, Seite 12
13 Legal and ethical framework conditions Projects generic data protection strategies patients informed consent biobanks ELN IT-Workshop II, Seite 13
14 Quality management Projects: validation of IT systems Standard Operating Procedures alternative monitoring strategies for IITs ELN IT-Workshop II, Seite 14
15 Interconnection of research and health care - vertical and horizontal integration Research Projects: Health Care Hospitals Medical Practitioner (in Private Practice) Patients Patient Organisations Research Institutions electronic health card / health professional card IT support for clinical guidelines interfaces between documentation systems in health care and research ELN IT-Workshop II, Seite 15
16 Outline Changes in framework conditions for clinical research Structure, programme and aims of TMF IT-Support for clinical trials From tools to infrastructure ELN IT-Workshop II, Seite 16
17 TMF IT support for medical research Evaluation, Development and Services 1. Evaluation & delivery of software systems clinical trial management software content management systems (CMS) 2. Software development (where no adequate systems available) pseudonymisation suite data converting tools (CDISC based) 3. Establishing of services via TMF electronic SAE management online assistant for informed consent forms ( pseudonymisation service (work in progress) electronic data custodianship services (work in progress)... ELN IT-Workshop II, Seite 17
18 SAE-Management Problem: To set up standardized SAE-Management including functions for electronic communication with authorities in accordance with national regulations for clinical trials 2005: Requirements analysis Evaluation of vendors and software 2006: Decision for one product Contracts between Vendor, TMF, Hosting-Provider and Users Building SAE-User-Group in the TMF, incl. Web-Forum 2007: 10 Research Institutions with over 20 client installations Customizing the software (reports etc.) Registration for electronic reporting of SAEs ELN IT-Workshop II, Seite 18
19 SAE-Management-Service User X User Y User Z Client-PC Client-PC Client-PC Admin-Client Admin-Client TMF-Office Internet Software- Provider DVD-Backup for System Recovery (no SAE-Data) if necess. Security Appliance (dedicated) Firewall + VPN Application Server (dedicated) Windows Server 2003 SE + VigilanceOne Application + Oracle-DB + Backup Client regular SAN for Data Recovery ( 64bit-Encryption 50GB Disk Space Fire Prot. Compartment Fire Prot. Compartment Fire Prot. Compartment ELN IT-Workshop II, Seite 19
20 Life Cycle of Clinical Trials and supporting Projects and Tools SAS Macros Meta-Analysis Epidemiology Data Integration Pseudonymization Service DMS/CMS RDE Hypothesis Protocol Development PID Service Site/Trial Preparation Subject Enrollment Standards (CDISC/HL7) Harmonized Terminologies Data Collection Monitoring Submission Data Analysis Reporting Trial Management Archiving SAE Management earchiving SAS Macros SDTM Mapper ATC Coding Interfaces to to CIS/LIMS RDE Mobile Computing ELN IT-Workshop II, Seite 20
21 Life Cycle of Clinical Trials The half cycle: From Rebecca D. Kush (CDISC): The Value of Standards for Clinical and Regulatory Personnel and Patients. DIA EuroMeeting, Paris, March 2006, Slide 7 ELN IT-Workshop II, Seite 21
22 Outline Changes in framework conditions for clinical research Structure, programme and aims of TMF IT-Support for clinical trials From tools to infrastructure ELN IT-Workshop II, Seite 22
23 Standards and terminology Projects and aims: evaluation of CDISC standards CDISC-SDTM based SAS-Macros harmonisation of documentation and ontologies, data dictionaries of clinical values contributions to harmonize standards from patient care (HL7/CDA, CCR, ) and clinical research (CDISC) to epidemiology and bioinformatics patient care public health, epidemiology pharmaceutical research clinical research infrastructures, biobanking biological research, bioinformatics TMF memberships: HL7, CDISC, HealthGrid, D-Grid (via MediGRID), Gematik advisory Board ELN IT-Workshop II, Seite 23
24 Tools based on CDISC-Standards SDTM-Mapper: converts XML-based CDISC- ODM into tabular format CDISC-SDTM supports interactive or automatic transformation ELN IT-Workshop II, Seite 24
25 Tools based on CDISC-Standards SAS macros for SDTM based clinical data 35 macros for production of standard tables and listings about inclusion/exclusion exceptions demographics medical history physical examination disposition exposure to study treatment concomitant medication laboratory data findings adverse events also available: example outputs, validation plan, dummy study data, ELN IT-Workshop II, Seite 25
26 Combining Tools to Infrastructure Medical Practitioner PID Service Hospital RDE Pseudonymization Service SDTM Mapper Reference DB IDAT + PID Medical Practitioner Study DB PID + MDAT Research DB PSN + MDAT SAS Macros ELN IT-Workshop II, Seite 26
27 Combining Tools to Infrastructure Medical Practitioner PID Service LF2873X9 Smith, John AE395Y64 Myer, Bill H7T945A8 Miller, Gil 67RZF342 Grant, Hugh Reference DB IDAT + PID Hospital Medical Practitioner RDE Study DB PID + MDAT Symmetric Pseudonymization Encryption PID Service > PSN: LF2873X9 > AE395Y64 SDTM Mapper Research DB PSN + MDAT SAS Macros ELN IT-Workshop II, Seite 27
28 Towards a Service Oriented Architecture (SOA) Institution with project oriented data storage (pseudonymized) Institution with data storage across projects (two-fold pseudonymized) Documentation System or RDE with Study-DB Research-DB SDB-Service PSD-Service RDB-Service Webservice-Integration (SOAP) or XML-based Filesystem-Connection Webservice-Communication (SOAP) by https with client certificates ELN IT-Workshop II, Seite 28
29 Remaining Problems and Challenges Federal structures and distributed responsibilities in Germany Political segmentation of health care and medical research Drawback for projects with dependencies on the patient care sector How to motivate for (time consuming) structured documentation? using (powerful, but complicated) data and IT standards? building up and harmonizing cross-sector data and IT standards? using quality standards? using of and working on one common IT infrastructure? Moving from project-driven approach to sustainable support and services ELN IT-Workshop II, Seite 29
30 Thank you. More Telematikplattform für Medizinische Forschungsnetze (TMF) e.v.
Telematikplattform für Medizinische Forschungsnetze (TMF) e.v. Berlin / GERMANY
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