Clinical Research
Learn about our clinical research units and the studies we support across a wide variety of medical disciplines
Clinical Research
We provide support for clinical research trials across Interior Health with local impact in urban centres and rural sites. Currently, we have three Clinical Research Units that support Phase II-V studies across a wide variety of medical disciplines. In addition, we support select remote studies.
Each of our Clinical Research Units supports investigator-initiated and sponsor-driven clinical trials, encompassing a wide range of medical specialties that may provide treatment (drug or device) options for patients and family members. In addition, we support retrospective chart reviews and data collection for registries.
Questions about clinical research can be directed to research@interiorhealth.ca
Kelowna General Hospital Clinical Research Unit
The unit covers 2,320 square feet located on the first floor of Strathcona Building. Outpatient space includes patient rooms for assessments and treatments, a medication storage room, laboratory space for collecting, processing and storing blood samples and dedicated office space for the Clinical Research Coordinators and Clinical Trials Pharmacist.
Royal Inland Hospital Clinical Research Unit
The unit is located on the third floor of the Alumnae Tower with 2,000 square feet including office space, a patient room for assessments and treatments, a medication storage room, and a dedicated office space for the Clinical Research Coordinators.
Penticton Regional Hospital Clinical Research Unit
The unit covers 2,300 square feet located on the second floor (SP2). This space includes patient rooms for assessments and treatments, a medication storage room, lab space for collecting, processing and storage of blood samples, and dedicated office space for the Clinical Research Coordinators.
Rural Sites
We offer remote research support to regional and rural centres within Interior Health depending on the type of trial.
Composition & services
We offer services to support investigator-initiated or sponsor-driven research from all health-care disciplines. These studies can be grant funded, industry funded, privately funded, or funded through one of our many hospital foundations.
- Each of the Clinical Research Units consist of Clinical Research Coordinators who are registered nurses, licensed practical nurses, and other medicine-educated individuals.
- We are also comprised of a dedicated Clinical Trials Pharmacist, Clinical Research Department Manager and Business Analyst.
- All Clinical Research Team Members have completed their certification in Good Clinical Practices, the Health Canada Division 5: Drugs for Clinical Trials Involving Human Subjects and the Tri-Council Policy Statement amongst other certifications. In addition, education in best practices is provided internally as well as by the Michael Smith Health Research and Collaborative Institutional Training Initiative
- We have expertise in a wide variety of areas such as stroke, cardiovascular disease, renal disease, endocrinology, hepatic, trauma, and virology research and many more
Investigators, whether they are the Qualified Investigator or the Co-Investigator, are required to complete their certification in Good Clinical Practices, the Health Canada Division 5: Drugs for Clinical Trials Involving Human Subjects and the Tri-Council Policy Statement amongst other certifications prior to working on a trial. In addition, Qualified Investigators and Co-Investigators are expected to complete all study specific training.
We offer services to investigators from trial inception through to execution. The clinical trial expertise is provided by our department staff, which include the following services:
Application Supported From Start to Finish
- Feasibility review
- Contract and budget review and negotiations
- Informed consent development
- Ethical review and submissions
- Operational approval submission
Study Preparation
- Development of source documentation
- Liaise with appropriate units
- Development of a recruitment plan
- Conduct training and education for research staff prior to the commencement of the study
Study Management / Administration
- Recruitment - screening, consenting & retention of participants
- Monitoring and follow-up with participants to ensure safety and efficacy
- Data collection and entry
- Receipt, storage, preparation, dispensing and monitoring of investigational products as well as destruction of investigational products upon study completion
- Staff are cross trained to support and act as back up coverage as needed
- Processing, storage and shipping of specimen collection
- Data entry
- Invoicing and account reconciliation
Onsite Clinical Care
- IV infusions
- Venipuncture with specimen collection
- Blood processing
- Vaccine administration
- Electrocardiogram
- Conduct various assessment tools
We operate with funds received from the studies. These service fees are based in accordance with the complexities of the trial, resources required and are in alignment with trial protocols, Interior Health Policies and Standard Operating Procedures.
Investigators and/or Sponsors are welcome to email Clinical Research regarding new studies, study budget and contracts.
Currently active research trials
The Clinical Research Department’s goal is to conduct research that will help to advance care and further expand medical knowledge. Studies currently being conducted within Interior Health are as follows:
Neurology
- FRONTIER - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset
- SECRET/TOP SECRET - Multicentre, prospective randomized open label, blinded-endpoint (PROBE) controlled trial of anticoagulation with Rivaroxaban versus standard of care in determining safety at 365 days in symptomatic cerebral venous thrombosis
Enrollment and follow-up of study participants concluded.
- ACT - Alteplase Compared to Tenecteplase in patients with Acute Ischemic Stroke: QuICR & OPTIMISE Registry based Pragmatic Randomized Controlled Trial
Enrollment and follow-up of study participants concluded.
- WALK & WATCH – Enhancing physical therapy best practices for improving walking after stroke
- OCEANIC-STROKE - A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
Renal
- ACHIEVE - Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease
- EMPA-KIDNEY - A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic Kidney disease
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
- RECORD - The Registry of persons with kidney disease Considering participation in Research Database.
Cardiac
- CLEAR SYNERGY OASIS 9 - A 2x2 factorial randomized controlled trial of Colchicine and Spironlolactone in patients with ST elevation myocardial infarction/SYNERGY Stent Registry - Organization to Assess Strategies for Ischemic Syndromes 9
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
- SAVE BC - Study to Avoid cardioVascular Events in BC (SAVE BC) - A Study to Support the Establishment of a Province-Wide Premature Cardiovascular Disease Family Program in British Columbia
- NODE 303 - Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
Enrollment and follow-up of study participants concluded; overall study results are pending.
- OCEAN - The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
- VANISH 2 - Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
- RASTA AF - Reversal of Atrial Substrate to Prevent Atrial Fibrillation
Cardiac Surgery
- TRICS IV - Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery: An international, multi-centre, randomized controlled trial to assess transfusion thresholds in younger patients undergoing cardiac surgery
- COMMENCE - Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgery A Randomized Controlled Trial of Mild vs Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery with Anterograde Cerebral Perfusio
- DEPOSITION – Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Surgical
- Helix - The Helix (Hemorrhage during Liver Resection: tranexamic acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
Infectious Disease
- COVID-19 ED REGISTRY - Creating a national registry of suspected and confirmed COVID-19 patients who present to acute care Emergency Departments (ED) has the potential to inform clinical decision-making, emerging treatment guidelines, resource allocation and planning in Canada in response to the global pandemic.
Enrollment and follow-up of study participants concluded.
Renal
- ACHIEVE - Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease
- RECORD - The Registry of persons with kidney disease Considering participation in Research Database.
Cardiac
- AEGIS - A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
- REFINE ICD - Risk Estimation Following Infarction Non-invasive Evaluation - ICD efficacy
- EMPACT MI - EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction
- OCEANIC-AF- Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotiC - Atrial Fibrillation study
Infectious Disease
- CATCO- A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients, in conjunction with the Public health emergency SOLIDARITY trial (World Health Organization)
Enrollment and follow-up of study participants concluded.
- COVID-19 ED REGISTRY - Creating a national registry of suspected and confirmed COVID-19 patients who present to acute care Emergency Departments (ED) has the potential to inform clinical decision-making, emerging treatment guidelines, resource allocation and planning in Canada in response to the global pandemic.
Enrollment and follow-up of study participants concluded.
- MOSAIC - Immunogenicity and adverse events following immunization with alternate schedules of authorized COVID-19 vaccines in Canada: MOSAIC study (Mix and match of the second covid-19 vaccine dose for SAfety and ImmunogeniCity)
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
Infectious Disease
- MOSAIC - Immunogenicity and adverse events following immunization with alternate schedules of authorized COVID-19 vaccines in Canada: MOSAIC study (Mix and match of the second cOvid-19 vaccine dose for SAfety and ImmunogeniCity)
Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.
Participant role in clinical research
A clinical trial is research that compares an intervention to the current standard-of-care (treatment available) or to a placebo. The intervention might be a drug, medical device, medical procedure or lifestyle modification (i.e., diet).
Clinical trials generally have participants randomized into a ‘study group’ compared to a ‘control group’. Participants in the study group receive the intervention that is being studied while participants in the control group will receive the standard-of-care or a placebo.
By comparing new interventions to current standard-of-care, researchers are able to determine if the intervention is equal or more beneficial than the current treatment. Most present day treatments were made possible by people who volunteered to be part of a clinical trial.
- Most of our studies are hospital based for both inpatients and outpatients.
- Clinical Research Staff will approach a potential participant while they are admitted to one of our research hospitals to see if they are interested in being a part of a trial. Only participants who have the condition being studied will be approached.
- For community-based trials, potential participants may have the opportunity to participate in a research trial through a referral based system or onsite recruitment.
- If the potential participant is interested, the Clinical Research Coordinator will go over the informed consent form. The consent form provides information about the trial as well as potential benefits and risks involved, and what would be required of the participant over the course of the trial.
- If the potential participant is not interested in participating in a trial, their decision will not impact their current level of care.
- If an individual is uncertain and/or needs more time to review the informed consent with their family and/or loved one, the Clinical Research Coordinator will leave them with the document and follow up with them at a later time.
- Once a potential participant agrees to participate in the trial, they will be required to sign the informed consent form.
- Every individual who is enrolled in a trial does so voluntarily. This means that the participant chooses to enroll in the trial on their own accord and can withdraw from the trial at any time. They will continue to receive the same level of clinical care even if they choose not to participate in the trial. Clinical research staff may be required to continue to follow the participant for a short period of time to ensure safety if they were on a certain investigational product (e.g., medication).
- During the course of the trial, information about the participant and any health information collected will be protected in accordance with privacy legislations. All participants’ information is kept confidential and is only accessed by authorized staff involved in the trial.
- As a participant in a clinical trial, you might receive access to an intervention (i.e., medication) that could potentially lead to a better health outcome.
- You may gain access to additional tests and more frequent follow-up with the medical research staff that will be monitoring the specific condition that is being researched.
- By participating in a clinical trial, you may gain a more in-depth understanding of your medical condition and the medications you are taking.
- You will be contributing to how future health care practice is done. This can lead to improved care for other people who also are impacted by the condition being studied.
- To maintain ethical and unbiased research, there will be no monetary or other form of payment for participants in a trial.
- Prior to being enrolled, interested participants will have a meeting with the Clinical Research Coordinator to review all of the information about the clinical trial. The Clinical Research Coordinator will review any known risks that might come with participating in the trial. Potential participants have the opportunity to ask the Clinical Research Coordinator or a physician any questions regarding the trial and/or their participation. Only after the individual has been fully informed about the trial, and had all of their questions answered, will they be able to consent to participate and start the research.
- The participant’s condition is monitored closely during the trial by Clinical Research Staff, including the Qualified Physician Investigator, for the effects of the research.
- All clinical trials conducted in Canada are approved by a Research Ethics Board and comply with regulations set out by Health Canada and the U.S. Food and Drug Administration.
- Should the participant have any concerns during their involvement in the study they have the right to discuss their concerns with the study coordinator and study investigator (physician). If the research participant continues to have concerns, or their concerns are not adequately addressed by the research staff they should contact the Ethics Board listed in their informed consent form.
Contact information
Leadership
- Dr. Devin Harris – Executive Medical Director, Research, Quality and Patient Safety
- Dr. Deanne Taylor – Corporate Director, Research
Training & Education/Quality Assurance
- Tess Topor – Leader, Clinical Research, RN, BN
Regulatory
- Dusty De Jesus – Clinical Research Coordinator
Contracts & Budget Negotiations
- Please contact us by email at ClinicalResearch@interiorhealth.ca
Clinical Research Team - Kelowna General Hospital
- Dr. Divna Calic- Clinical Trials Pharmacist, B.Sc. (Pharm), PhD
- Marie McClelland – Clinical Research Coordinator, RN
- Camille Galloway – Clinical Research Coordinator, RN, BScN, MSN
- Alissa Smith – Clinical Research Coordinator, BA
- Kaylee Neill - Clinical Research Coordinator, RN, BScN
- Nicole Foreman - Clinical Research Coordinator, RN, BScN
- Paige Stevens – Research Assistant, BSc
- Dr. Amna Ahmed – Research Volunteer, MBBS
- Tyson Cuylle – Research Volunteer, BSc
- Dr. Robin Blanchard – Manager, Research Compliance & Capacity, PhD, CE
- Holly Buhler - Manager, Research Data & Special Projects, MMedSc, MGIS, CE
Clinical Research Team – Penticton Regional Hospital
- Susan Keast – Clinical Research Coordinator, RN, BScN
- Jennifer Menzies – Clinical Research Coordinator, BSc, MSc
- Jason Curran – Manager, Rural Research & Physician Engagement, BSC, BJourn, MPH
Clinical Research Team – Royal Inland Hospital
- Christian Allera – Clinical Research Coordinator, RN, BScN
- Dani Wittal, Clinical Research Coordinator, RTT, MSc
- Erika Byrne, Clinical Research Coordinator, RN, BScN
- Gretchen Zirnhelt, Clinical Research Coordinator, LPN
- Lindsay Milton, Project Coordinator
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