In 2021, Dr. Amit Garg was appointed as Associate Dean, Clinical Research at the Schulich School of Medicine & Dentistry with the goal of accelerating the design and conduct of clinical trials. Dr. Garg has worked with local partners including the medical school, local hospitals, and research institute to develop the Accelerating Randomized Trials (ART) platform, which supports faculty in their trial aspirations and improves capacity to conduct different types of clinical trials (e.g., first-in-human trials and pragmatic trials). The ART platform is divided into three streams that offer different services and training opportunities to researchers. The Pragmatic Trials Stream, designed to support researchers as they plan and execute large-scale pragmatic trials, has four trial coordinators, two research assistants, a manager, two biostatisticians, two methodologists, and assistants focused on all trial phases. It is supporting six large trials with a total of 80,000 patients. One of the trials, Dial-Mag, is being conducted in 150 hemodialysis centres across four provinces. Over the next decade, this stream aims to on-board more than 20 large-scale trials, streamlining the process of registry-based trials in partnership with national organizations such as Health Data Research Network Canada.
The Clinical Trial Unit at the Rady Faculty of Health Sciences has experience in designing and conducting large multi-national randomized trials from project inception to completion. The Unit’s expertise in leading platform trials is a notable strength that was realized during the COVID pandemic. The diverse skills of the trial unit staff reflect the skillsets required to successfully conduct and complete traditional and novel RCTs. In addition to contracting, insurance and regulatory proficiency, the unit has been recognized as a leader in Bayesian adaptive platform trials.
The Canadian Center for Vaccinology (CCfV) is Canada’s only fully integrated collaborative vaccine research facility spanning clinical trials/evaluation, basic science, and social science. CCfV serves as a critical “academic pipeline” for Canadian vaccine priorities - from the development of promising new vaccine candidates from Canadian and international companies, to applied public health research that supports timely public health decision-making. CCfV leads Phase 1–4 clinical trials in all age populations, from infants to the elderly. Over the past 15 years, the center has developed a specialization in early phase vaccine clinical trials, with more than 25 such trials. In 2020-21 CCfV was approached to undertake five Phase 1 trials for “made in Canada” COVID-19 vaccines, three of which are completed. Currently CCfV is leading or collaborating on 15 COVID projects including both national and international studies on pandemic policies and programs in equity-deserving populations, five COVID adult and one pediatric vaccine clinical trials; two international COVID vaccine clinical trials, and six national vaccine safety and surveillance studies in various populations. CCfV clinical facilities include a 7,000 sq. ft. full-containment Vaccine Challenge Unit (VCU) specifically designed for controlled human infection studies – the first of only two such units in Canada. CCfV investigators are currently conducting a pertussis human challenge study in the facility, in partnership with the US Centers for Disease Control and Prevention funded by the US National Institutes of Health and CDC.
Canadian VIGOUR Centre (CVC) is an academic research organization specializing in comprehensive full-service management of clinical trials of cardiovascular therapies, including study design, managing, monitoring, analyzing, and reporting trial results. Since inception in 1997, it has designed and delivered 72 clinical trials in CV medicine and surgery, including over 20,000 patients from Canada, and biosamples to match (>200,000 ECGs, >10,000 biosamples). In addition, large-scale datasets held by CVC represent six million people in Canada. Some of the 'firsts' and practice changing trials include time-to-treatment trials with fibrinolytics for myocardial infarction (establishing these as standard of care from first point of contact through to the hospital), the largest mega-trial in acute heart failure, the pivotal trial in a biomarker-guided strategy in heart failure, lipid lowering therapy trials with statins, ezetimibe, and PCSk9 inhibitors, and the largest trial in dietary sodium restriction in heart failure.
The UBC Centre for Cardiovascular Innovation – Centre d ’Innovation Cardiovasculaire (CCI-CIC) is a new UBC Academic Research Centre. Since its inception 2 years ago, the Centre has grown exponentially. There are currently 85 investigators representing all health authorities in BC with over 40 experienced and trained clinical research staff including statisticians, data managers, information technology (IT) professionals, finance/ contract management experts, and clinical research coordinators and managers. The Centre is running over 30 national and international high-impact clinical trials, registries, and investigator-initiated studies along with over 70 site-based clinical studies. Research studies at CCI-CIC encompass acute coronary syndromes (ACS), interventional and structural cardiology, cardiovascular surgery, arrhythmia and heart failure, cardiovascular disease (CVD) prevention, women’s heart health, adult congenital, cardiology-oncology, and sports cardiology. CCI-CIC is also coordinating studies for Urology, Neurology, and Pharmaceutical Sciences. Clinical trials range from large scale industry funded RCTs to federal/provincial funded clinical studies.
The CHU de Québec-Université Laval is the largest Health Care Center in the province of Québec and more than 700 scientists form its research center. The Clinical Trial Unit is based within the Population Health and Optimal Research Practices (SPPOS) Unit of the research center. The CTU has 3 trial coordinators, 6 research assistants, 2 program managers, 3 statisticians, 4 data engineers, 2 data scientist, 4 contracts officers, 2 quality assurance HQP, and close to 60 scientists. The CTU has expertise in conventional parallel group phase 3 trials and international trials. It has expertise in adaptive platform trial design, leads a trial within REMAP-CAP in Canada and developed the new international BRAINapt platform trial in TBI.
The CTU has access to SCIENTA, the Data Development and Exploitation Center of the CHU de Québec-Université Laval and brings together electronic medical data from the establishment's clinical and administrative systems. The Data Lake offers services and support to secondary users by allowing the integration, validation and analysis of structured and unstructured data on health and social services information or compiled for research purposes, including automatic data extraction for trials.
The RIMUHC is one of the largest clinical trial units in Canada and comprises 600 researchers, 1300 trainees and 1500 support staff. We are closely intertwined with McGill University, the McGill University Health Centre, and the Montreal Children's Hospital. The RI-MUHC leads national and international clinical trials that are investigator initiated and/or linked with the private sector, working with patient partners. Our scientists provide training and mentoring to a rich cohort of outstanding McGill graduate students. The RI-MUHC offers expertise in the areas of clinical trial design, management, training and implementation through the McConnell Centre for Innovative Medicine, which is fully equipped to conduct phase 1, 2 and 3 trials, allowing us to help achieve the collective goals of the ACT consortium. The Clinical Innovation Platform, embedded within RI-MUHC, allows us to advance patient care based on clinical trial results. We contribute to and lead development of diagnostic and therapeutic strategies and technologies brought to market. We have expert trialists in appropriate prescribing, oncology, cardiology, respirology, infectious diseases, pediatric gene therapy, and more. Practice-changing randomized controlled trials led by our institute have been published in the NEJM, such as short course TB therapy in adults and children, and studies that established the evidence base for repurposed medications for the treatment of COVID-19.
The Health Policy Trials Unit, Centre for Health Policy, O'Brien Institute for Public Health at the University of Calgary works to ensure health policy decisions are informed by rigorous scientific evidence. Policy trials answer critical questions about which social, economic, and health care interventions improve health and why. Located within the new Centre for Health Policy at the O’Brien Institute for Public Health, the Health Policy Trials Unit contributes to the Centre's mission to engage citizens, patients, community groups, researchers, governments, clinicians, and health system leaders to identify, test, and scale up policies with the greatest potential to improve health. Anchored by community and patient partnerships, our unit is situated at the intersection of several research and innovation partners at the Cumming School of Medicine that provide big data access, statistical, and machine learning methods and analytical support, trial design expertise, research administration, and knowledge translation including the Clinical Research Unit, the Centre for Health Informatics, and the Interdisciplinary Chronic Disease Collaboration. The Health Policy Trials Unit has close linkages with Alberta Health Services’ Strategic Clinical Networks—groups of clinicians, patients, and researchers passionate and knowledgeable about specific areas of health that work to identify innovative ways of delivering care that improve health care quality and outcomes.
MICYRN is a federal not-for-profit, charitable organization founded in 2006 to build capacity for high-quality, applied health research. The network links 21 maternal and child health research member organizations based at academic health centers in Canada. MICYRN is affiliated with more than 25 practice-based research networks, provides support to new and emerging teams, and has established strong national and international partnerships. In support of the clinician-scientists and clinician-investigators in the maternal and child health research space (around 150 investigators in the past 3 years), MICYRN has acquired the expertise to function as a de-centralized Academic Research Organization (ARO), a first in Canada for the non-oncology pediatric clinical trial space. The de-centralized ARO infrastructure offers the pre-award services of grant consultation, budget review, and protocol optimization including national and international scientific depth. The post-award services support the maternal-child health community by facilitating and/or providing regulatory application assistance, coordinated ethics submissions in partnerships with the CHEER initiative, quality assurance and monitoring, contract negotiation and facilitation, data management, and project management. In the past 24 months, MICYRN has provided pre- and post-award ARO services for over 20 clinical trials projects and currently serves as the collaboration centre for the CIHR Canadian Pediatric COVID-19 Research Platform POPCORN.
The Ottawa Methods Centre (OMC) at the Ottawa Hospital Research Institute has a 17-year history of conducting clinical trials locally, nationally, and internationally. Close to 1000 trials (50,800 patients), including 378 industry trials, have been initiated at The Ottawa Hospital in the last five years in numerous fields, including critical care, emergency medicine, respirology, infectious diseases, renal transplant, transfusion medicine, stroke, perioperative medicine, and perinatal health. The OMC has 21 scientists and close to 40 staff. OMC trialists have been at the forefront of innovative trial design, including pragmatic trials, early-phase translation, and cluster randomized trials.
OMC is also home to Office for Patient Engagement in Research Activities (OPERA) and the BLUEPRINT team. OPERA supports patient-oriented research through consultations, training, resources, and additional research to advance the body of knowledge in this area. OMC’s BLUEPRINT program develops novel approaches to designing and optimizing clinical trial protocols for early-phase or first-in-human trials to accelerate bench-to-bedside translation.
Finally, OMC counts the REthinking Clinical Trials (REaCT) program among its many successes. Pioneered by Dr. Dean Fergusson and Mark Clemons, REaCT is the most extensive pragmatic cancer clinical trials program in Canada, with more than 2,700 patients participating in 17 clinical trials at 15 centres in Canada.
A research institute of McMaster University and Hamilton Health Sciences, PHRI specializes in large international clinical trials. Worldwide PHRI studies have enrolled >400,000 participants in >100 RCTs, with >20 trials enrolling ≥10,000 participants each; a dozen RCTs led by PHRI have resulted in global regulatory drug approvals. PHRI has led large trials in: cardiovascular prevention that have collectively randomized >100,000 people and have led to 3 regulatory approvals; diabetes trials that have collectively randomized >75,000 patients and have changed international guidelines; perioperative and cardiac surgery trials that have collectively randomized >47,000 patients and have impacted care globally; atrial fibrillation trials that have collectively randomized >40,000 patients and have led to regulatory approvals and have changed practice; and more.
PHRI has 79 trial coordinators, 64 research assistants, 6 program directors/managers, 17 statisticians, 14 statistical programmers, 28 contracts and finance HQP, 39 computing HQP, a team with expertise in shipment of study materials and importation of biospecimens, 4 quality assurance HQPs, and >50 scientists. PHRI has biobanking capabilities for trials and has developed Canada’s largest research biobank.