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How to promote research and health care development by local and international collaboration

How to promote research and health care development by local and international collaboration between universities and hospitals. Lars Wallentin Professor Cardiology Uppsala Clinical Research Center Uppsala University, Sweden. Uppsala Clinical Research Center

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How to promote research and health care development by local and international collaboration

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  1. Howtopromote research and healthcaredevelopment by localand international collaboration betweenuniversities and hospitals. Lars Wallentin Professor Cardiology Uppsala Clinical Research Center Uppsala University, Sweden

  2. Uppsala Clinical Research Center an independent academicnon-profit clinicalresearch center within Uppsala University and Uppsala County Council / University Hospital an internationallyleading competence center for clinical research, clinical trials, quality registries, biobanking and biomarker analyses. providescompetenceand technologytotransfer innovative conceptsintotranslational research projects, clinicaltrials and register-basedqualityenhancementprograms. Uppsala University Uppsala University Hospital

  3. Biomedical center (BMC) Uppsala University Uppsala University Hospital

  4. Our mission • To develop and improve health care by performing research and supporting clinical research, quality registries and quality enhancement in Sweden and internationally. Quality registries – peer review Clinical reality Scientific evidence – Guidelines Quality enhancement New treatment / Clinical Trials Diagnostic methods

  5. Academic collaborations

  6. Academic collaborations

  7. UCR Organisation • Board of UCR • UCR Executive Director is supported by the Board of UCR consistingoffivemembersrepresenting the University and Health Care Organisation in Uppsala • CEO of the Uppsala Academic Hospital (chairman) • Vice-vice chancellor for medicine och pharmacy, Uppsala University • Dean of the medicalfaculty, Uppsala University • Representative of the pharmaceuticalfaculty, Uppsala University • Politicalleaderofhealthcare in Uppsala County Council

  8. UCR Organisation 2014 Executive director Jonas Oldgren 3 Scientific Directors (CV diesase, Cancer, Epidemiology Administrative Manager Lena Ohrt Grünberg QA ManagementCatherine Mai-Trang-Pham UCR Faculty / Fellows IT Service Sören Gustafsson Communication / Ext. RelationsUlla Nässander Schikan UCR Laboratory Agneta Siegbahn Clinical Trials Inger Ekman Uppsala Biobank Anna Beskow UCR Statistics Bodil Svennblad Maria Bertilsson Quality Registries Peter Hedman Monika Sterner CEC Ulrika Boden

  9. Personnel UCR 2013 • UCR Director – UCR faculty, fellows 23 • QualityRegistries 29 • Clinical Trials19 • UCR statistics 18 • Uppsala Biobank 8 • UCR Laboratory 6 • IT-support 5 • Administration/QA/Communication 11 • Total: 119

  10. Clinical Trials

  11. Network Application Agreement Project leaders Protocol Education Biobank Laboratory Clinic Clinical Report § Monitoring/ Audit Rules and regulations UCR Clinical Trials Clinical event classification SAE-report/ SUSAR CRF, Database DM, Statistics Pharmacy

  12. UCR Clinical trials - an ARO Academic partners Pharmaceutical / Biotech Abbott AstraZeneca Axelar AB BoehringerIngelheim Boston Scientifics Bristol-Myers Squibb Ely-Lilly GlaxoSmithKlein InfraRedX Medco Medtronic Oncopeptides AB Pfizer Pharmalink AB Philips Roche Sanofi-Aventis Strama Lidds Etc. Anesthersiology Diabetes Genetics Dermal disease Infectious disease Internal medicine Cardiology Surgery Neonatology Neurology Gynecology Nephrology Nutrition Odontology Oncology Psychiatry Radiology Reumatology Otorhinolaryngology etc.

  13. Data management

  14. UCR Data Management - Experience • Different therapeutic areas • Life Science companies and academic researchers • Investigational drug trials and medical device studies • Long experience of Clinical Trials from Phase I to IV • ECRIN certified 2012 (European Clinical Research Infrastructure Network)

  15. Clinical Event Classification (CEC)

  16. Central Event Adjudication in clinical trials

  17. UCR Clinical Event Classification (CEC) • UCR started with CEC adjudications in 2008 and have so far adjudicated approx. 50,000 events • Responsible for CEC in large global multicenter trials as well as in smaller academic and register trials • Selected by FDA as one of five centers in an international project aiming to standardize endpoint definitions and evaluate adjudication processes • Global network of academic partners • Expanding organization with many new projects

  18. UCR Statistics

  19. UCR Statistics 18 statisticians Clinical Trials Observational Studies Randomization and follow-up in registries Consulting Creation of ADB Education

  20. UCR laboratory and PLA plattform

  21. Platforms for Biobanking (Ubb) and Laboratory analyses (UCR lab) in collaboration with hospital laboratories UCR Laboratory • Biochemical and • Genetic analyses Sampling Uppsala Biobank • Storage Temporary local storage Other research laboratories Flight transportation Freeze transportation Batches of samples

  22. UCR Laboratory • Equipped with state-of-the-art instruments • Large number of assays • Highly qualified personnel • Accredited according to ISO standard • We have analyses more than 300 000 proteins/biomarkers during the last 5 years in international and global studies (Plato, Rely, Aristotle, Thrombogenics, Stability, CHillMIetc)

  23. The Clinical Biomarkers Facility SciLifeLab in Uppsala • Placedwithin the UCRlab and the firstplatform for multiplexing in largescaleanalysisofbiomarkerswith PEA techniques and singleplex PLA • CollaborationProf Ulf Landegren and associateprofMasoodKamali-Moghaddam, PLA proteomicfacility, UU • OLINK company • A panel includingbiomarkers for cancer is avaible for clinical studies • A panel includingbiomarkers for cardiovasculardiseaseswill be avaibleoctober 2013 • MicroRNA panels in plasma

  24. Publication Management

  25. ChairmanPublicationsCommittee Academic Statistics Company Model Publications & Presentations (PPP) Scientific Publications Management (UCR) Substudies: Biomarkers GWAS Angiography ECG Health Economy Committee of National Coordinators Other researchers Manuscript working groups

  26. >130 members of PLATO Publications & Presentations

  27. UCR 2013 Clinical Trial Flagship Projects

  28. Clinical Quality Registries (Q-reg)

  29. National Quality Registers - Overview Registry form Reports Electronic patient records Quality Registry Other registries Research data base Publications

  30. Our services Registry owner advice and support Quality registry development and production IT, training, monitoring, user support Annual reports Quality enhancement Methodology, requirements, project management Statistical support and advice Quality registries home pages Legal advice

  31. UCR: a national center for quality registries AURICULA* - Förmaksflimmer- och antikoagulationsregister ERAS - Enhanced RecoveryAfterSurgery GallRiks* - Register för gallsjukdomar ICMART- International registry for In vitro fertilization Kardiogenetikregistret Kateterablationsregistret* Mödrahälsovårdsregistret/Graviditetsregistret* NRS* - Nationella Registret över Smärtrehabilitering Q-IFV*- In vitro fertilization RiksSvikt* - Svenska Hjärtsviktsregistret, patienter med hjärtsvikt Senior Alert* - Nationellt kvalitetsregister för vård och omsorg SOReg* - Scandinavian ObesitySurgeryRegistry SPAHR* - Svenskt register för pulmonell hypertension SVAR - Svenskt Akutvårdsregister Svedem* - Svenska Demensregistret SWEDCON* - Barnhjärtregistret (inkluderar GUCH) SWEDEHEART* - Combination of RIKS-HIA, SEPHIA, SCAAR och Svenska Hjärtkirurgiregistret SWEDEVOX* - Register för oxygenbehandling och respiratorbehandling i hemmet SWEDVASC* - Nationellt register för kärlkirurgi TBI - Traumatic Brain Injury ThoR - Allmän Thoraxkirurgi Webrehab Sweden* - Kvalitetsregister inom rehabiliteringsmedicin *Nationellt quality registry with support from Sveriges Kommuner och Landsting (SKL)

  32. SWEDEHEART - Coverage

  33. Annual reports www.ucr.uu.se

  34. Annual reports

  35. Quality at a glance

  36. On-line reports Reference period Mean 85 % of patients Outcome period Mean 90 % or patients Intervention/education/ Organisation change

  37. RIKS-HIA Quality index 2005 2011

  38. RIKS-HIA Quality index Association to start of public reporting Larsson et al. Health Affairs 2012; 31(1)

  39. Mortality Post-MI > 75 years 30 day mortaiity 65-74 years < 65 years

  40. Registry based prospective Randomized Clinical Trials (RRCT) – a new concept for clinical trials RRCT - The NEW Flagship

  41. Information onoral/written consent Did the patient consent? Are inclusion and exclusioncrieteriamet?

  42. Two questions need to be answered: Did the patient consent orally? Are inclusion and no exclusion criteria met? Did the patient consent? Are inclusion and exclusioncrieteriamet?

  43. Randomize and save the data Did the patient consent? Are inclusion and exclusioncrieteriamet?

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