Clinical Research

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.  

• 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.

•    The Canadian Clinical Trials Asset Map (CCTAM)
•    CCTAM - BC Showcase
•    Clinical Trials database provided by US National Library 
•    Clinical Trials BC
•    REACHBC

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. 

Enrollment and follow-up of study participants concluded.

• 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. 

Enrollment and follow-up of study participants concluded.

• 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

Enrollment has concluded for this study; follow-up of currently-enrolled participants is ongoing.

Renal

• ACHIEVE - Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease

Enrollment and follow-up of study participants concluded.

• 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. 

Enrollment and follow-up of study participants concluded.

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
• ARTEMIS - Effects of Ziltivekimab versus Placebo on cardiovascular outcomes in patients with acute myocardial infarction.

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 Perfusion. 
   
• DEPOSITION – Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery. 

Enrollment and follow-up of study participants concluded.

• REN-007- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery (The PROTECT Study)

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.

Chronic Scrotal Pain

• ST-CP-202 - This multi-center, phase 2, randomized, single-blind, three-arm, active-controlled study is comparing repeat doses, every 28 days, of standard of care (SOC) plus ST-01 against SOC plus 1% lidocaine HCL in men experiencing chronic scrotal content pain (CSCP). 

Stroke

• CAMAROS - The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke. 

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.

• 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.