Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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66 BRITISH COLUMBIA FRASER HEALTH AUTHORITY Burnaby Hospital Regional Cancer Centre Burnaby Hospital Regional Cancer Centre is a community oncology site that provides cancer treatment (http://research.fraserhealth.ca/clinical_trials/clinical_trials_research_groups/). It conducts Phases II and III clinical trials with novel agents as well as expanded access and supportive care studies. In addition to sponsor-initiated studies, the Centre is also involved in investigator-initiated trials. It has one Principal Investigator (Lam, Wendy), whose details can be found in Appendix 6, and two co-investigators (Stuart, David; Yu, Simon). Staff include the following: Study Nurses/ Coordinators 1 Data Managers/ Coordinators Pharmacy Staff Laboratory Staff Admin 4 1 2* 2* 4 * Available for research projects The division sees about 500 new patients per year. For new studies, protocols are reviewed by the Research Coordinator and Centre Manager, along with any departments (i.e.. lab, pharmacy, radiology) that will be utilized. They are then submitted to the Fraser Health REB for approval. With a fully trained Research Coordinator, all studies comply with ICH/ Good Clinical Practice guidelines. Contact: Tkachuk, Ryan. BSc. Research Coordinator: Tel: 604-836-5340. tkservices@shaw.ca. Cardiology Clinical Trials Inc., Surrey Memorial Hospital Surrey Memorial Hospital Cardiology Clinical Trials Inc. (http://research.fraserhealth.ca/clinical_trials/ clinical_trials_research_groups/) conducts both inpatient and outpatient Phases II, III, IV clinical trials in the areas of: • Acute Coronary Syndromes (hospitalization with heart attack/angina) • Congestive Heart Failure (acute in hospital as well as outpatient studies) • Lipid lowering treatments (patients with high cholesterol) • Cardiovascular disease and diabetes combined. Most of these studies are for novel drugs aimed at preventing heart attacks and strokes. The Unit also participates in a registry and a quality of life initiative for acute coronary syndrome. On average there are 15 studies ongoing at various stages at any given time. The research group consists of the following eight cardiologists whose details are listed in Appendix 6: • Bon, Richard • Manyari, Dante • Cheung, Stephen • Pearce, Stephen • Dong, Raymond • Shariff, Salima • Kornder, Jan • Tan, Peter
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 67 Staffing is as follows: Study Nurses 1 Data Entry Clerk Pharmacy Staff Laboratory Staff Admin 4 (2 full time/ 2 1 0 0 3* part time) * 1 Manager (who is also one of the study nurses), 1 Assistant, 1 Financial Director. The unit uses the hospital pharmacy in its conduct of clinical trials if necessary. Laboratory tests are conducted at the hospital or private laboratories. Quality control/ assurance procedures are based on detailed and extensive Standard Operating Procedures and are compliant with ICH, Health Canada, and FDA Good Clinical Practice (GCP) guidelines. All projects are approved by the REB prior to initiation and all research staff are trained appropriately in clinical trials, GCP regulations and guidelines, and the SOPs. The Unit also participates in monitor and study termination visits and audits. Contact: Breakwell, Lynn. RN. Tel: 604-587-3720. lynn.breakwell@fraserhealth.ca. Fraser Health Critical Care Group Critical Care research in Fraser Health is conducted at Surrey Memorial (SMH) and Royal Columbian (RCH) Hospitals (http://research.fraserhealth.ca/clinical_trials/clinical_trials_research_groups/). The focus of the research program is on contributing to publicly funded trials, [e.g. Thromboprophylaxis; ARDS; Sedation management, Life support outcomes for Octogenarians; Ventilator Associated Pneumonia; H1N1] largely in collaboration with the highly successful Canadian Critical Care Trials Group. Other research includes industry funded studies [e.g. Sepsis; Surfactant in Acute Lung Injury; Novel Vasopressors] and small investigator driven pilot studies [e.g. Topical antibiotics to reduce central line infections, dosing of antibiotics in non dialysis dependent renal failure]. Industry-sponsored trials include Phases II and III. The key Principal Investigators are: • Reynolds, Steven (Intensivist and ICU Research Director, Royal Columbian Hospital) • Keenan, Sean. Their details can be found in Appendix 6. Contact: Svetik, Miroslav. ICU RCH Research Coordinator. miroslav.svetik@fraserhealth.ca. Mans, Sheilagh. ICU SMH Research Coordinator. Sheilagh.Mans@fraserhealth.ca. Multiple Sclerosis Clinic Based at Burnaby Hospital, the Fraser Health Multiple Sclerosis clinic provides a comprehensive, community based clinic to the Fraser Health region (http://research.fraserhealth.ca/clinical_trials/clinical_trials_research_groups/). The clinic has 13 multidisciplinary team members (4 neurologists, urologist, neuro-ophthalmologist, psychiatrist, rehab medicine, MS certified nurse, physical therapist, occupa-
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