Overview of Clinical Trial Research in Fraser Health. Fraser Health Authority

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1 Overview of Clinical Trial Research in Fraser Health Fraser Health Authority

2 FH Strategic Imperative Be an Academic Healthcare Organization that Improves Health Outcomes and Health Services Sustainability Through Teaching, Education and Research

3 FH Strategic Imperative Objectives Foster a culture of curiosity Develop networks to support grant and industry-sponsored research

4 FH Strategic Imperative Increase FH participation in research activity!

5 Clinical Research September 01, 2005-March 31, 2010 # Active, Completed, Pending Studies 769 All 216 active or pending approval Study type 56% Clinical 43% drug

6 Researchers Clinical Research September 01, 2005-March 31, active FH PIs 29 active clinical trialists 67 Affiliated Academic Researchers 33 active

7 Funding Clinical Research 30% Grant funded 16% Industry sponsored 35% Unfunded 19% Other funding Sept 2005-March 31, 2010

8 INPUTS 20,119 research subjects!

9 FH Sites

10 Department of Evaluation and Research Services

11 Services Clinical Programs Cardiac Sciences Critical Care Emergency Home Health End of Life Laboratory Medicine Maternal, Infant, Child, Youth Medical Imaging Medicine Mental Health and Addictions Older Adult Pharmacy Primary Health Care Public Health Rehabilitation Renal Residential Care and Assisted Living Surgery Trauma

12 Research Coordinator New position, part-time (November 2010) Department of Evaluation and Research Services Role of Research Coordinator Provide support to FH physician researchers in all Clinical Programs to develop and conduct clinical research Outreach Goal Services Identify and support (at minimum) one physician researcher for each Clinical Program

13 Research Coordinator Research Development Walk researcher through research process Facilitate consultation with Epidemiologist (Michael Wasdell) and Research and Grant Development Facilitator (Magdalena Swanson) Research idea Research question Team building Services Protocol writing Publication/Knowledge Translation

14 Services Research Coordinator Regulatory Management Preparation, submission and maintenance of all regulatory documents for duration of study Ethics application (initial, amendments, renewals, closure) Consent forms Clinical trial application to Health Canada Clinical trial registration SOPs and N2 membership

15 N2 (Network of Networks) DERS is new member of N2 (April 2011) N2 is a membership organization Funded by CIHR Focus on creation and distribution of training, quality assurance and best practice tools SOPs National FH specific Industry (Pfizer will accept for 2 years)

16 Research Coordinator FH Approval Services Preparation, submission and maintenance of all FH documents DAR (Department Agreement for Providing Research-related Services) Form and obtain all departmental signatures Liaison with FH department that provide research related services (such as lab, pharmacy, health records) LOA issued by Susan Chunick, Director

17 Research Coordinator Research Start-Up Services Document management Subject recruitment and consent procedures Budget development and negotiation with sponsors Organization and procurement of human resources Maintenance of financial records Processing clinical trial agreements

18 The Future Building on Success

19 Cardiac Sciences Clinical Research Liz da Silva (nutritionist), Dr. Jorge Bonet, Carol Galte, Dr. Leanne Kwan, Dr. Tim Green Vitamin D Supplementation in Heart Failure (Pilot Study) 1 st investigator-initiated Health Canada Clinical Trial Application in FH

20 Clinical Research Critical Care Liz Rohrs and Dr. Steve Reynolds Esophageal Pressure Guided Mechanical Ventilation Retrospective Case Control Study Creation of formal collaborative approach to research Dr. Steve Reynolds Research Scholar Award A Pilot Study Evaluating a Procalcitonin-based Algorithm Determination of Antibiotic Duration in Critically Ill Patients

21 Clinical Research Emergency Dr. Adam Lund Cannabis and Motor Vehicle Crashes: A Multicentre Culpability Study Create research education sessions conducive to physician schedule

22 Clinical Research Medicine Dr. Julie Lee, Dr. Jennifer Klinke, Dr. Agnieszka Barts Metformin In Women With Type 2 Diabetes In Pregnancy Trial Dr. Jennifer Klinke Insulin pump vs. conventional insulin for Type 1 diabetes in pregnancy: A retrospective review Dr. Dave Williams Impact of delayed transfer of COPD patients from the ED to the medical units: A retrospective review

23 Surgery Dr. Peter Blair Clinical Research Retrospective Review of Open versus Laparoscopic Appendectomy Methodology for chart review developed by Mike Wasdell for this pilot Dr. Peter Blair, Dr. Dave Konkin Management of the Open Abdomen with the ABRA Dynamic Fascial Closure System: A retrospective review Writing of grant-in-aid contract

24 Clinical Research Residential Care/Assisted Living Dr. Dave Fletcher Investigating the use of Hydrochlorathiazide and increased hip fractures in older adults (under development)

25 Clinical Research Upcoming studies with DERS support Diagnostic Imaging End of Life Home Health Laboratory Medicine and Pathology Maternal, Infant, Child and Youth Rehabilitation

26

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