RI-MUHC researchers will lead or co-lead multiple projects awarded a total of $55 million from the Canadian Institutes of Health Research
Randomized clinical trials (RCT) are studies that measure the safety and effectiveness of novel medical treatments or interventions. Essential to medical knowledge and patient care advancement, they allow the Canadian population access to new treatments. However, the COVID-19 pandemic has highlighted barriers to the timely and effective implementation of RCTs in Canada, revealing the necessity to modernize the way we design and conduct clinical trials.
A strong and creative leader in clinical research, the Research Institute of the McGill University Health Centre (RI-MUHC) is committed to help overcome these barriers and boost the impact of clinical trials in Canada. As announced today by the Canadian Institutes of Health Research (CIHR), RI-MUHC researchers will lead or co-lead large-scale projects that will improve the development and conduct of clinical trials and expand access to experimental treatments for underrepresented communities. These projects will receive a total of $55 million from the CIHR Clinical Trials Fund.
CANTRAIN – a unique training initiative to improve clinical trials
The CANadian Consortium of Clinical Trial TRAINing (CANTRAIN) project, awarded $11.3 million dollars over three years, will adopt an equitable, diversified and inclusive approach to training the professionals who conduct clinical trials, through collaborations across Canada. Initiated by Dr. Jean Bourbeau, respirologist and director of the Centre for Innovative Medicine (CIM) at the RI-MUHC, Dr. Suzanne Morin, director of the Division of general internal medicine and scientist at the RI-MUHC, Dr. Kaberi Dasgupta, director of the Centre for Outcomes Research and Evaluation (CORE) at the RI-MUHC and Dr. Louise Pilote, deputy director of the RI-MUHC, the nine-province consortium will enable all stakeholders involved in clinical trials to work together more effectively and will fill the gap that presently exists across public institutions, pharmaceutical and biotechnology industries.
“In order to proactively and efficiently lead impactful clinical trials, we need highly qualified personnel who are thoroughly trained to improve the design and execution of these trials,” says Dr. Bourbeau, who is also a senior scientist in the Translational Research in Respiratory Diseases Program at the RI-MUHC and a professor in the Department of Medicine at McGill University. “Our goal with CANTRAIN is to harmonize and enhance training, mentoring and networking for postgraduate students in health sciences, clinical research professionals, trialists and coalition partners. We will promote adherence to standards as well as principles of continuous improvement through an accessible and innovative training and accreditation platform.”
For more information on CANTRAIN, see Appendix 1 below.
ACT – a consortium to improve access to clinical trials for all
RI-MUHC researchers will participate in another consortium that aims to boost the impact and speed of Canadian-led clinical trials to improve health outcomes. Through the Accelerating Clinical Trials (ACT) Canada Consortium, new treatments, drugs, devices and biotechnology will be tested, providing innovative experimental treatment and solutions to a larger and more diversified population.
The RI-MUHC’s participation in ACT is co-chaired by researchers Dr. Louise Pilote, who is also a general internist, a scientist in the Cardiovascular Health Across the Lifespan Program and a professor in the Department of Medicine at McGill University and Dr. Sushmita Pamidi, a respirologist, scientist and associate leader of the Translational Research in Respiratory Diseases Program. Dr. Emily McDonald, an internist and scientist in the Infectious Diseases and Immunity in Global Health Program, will work as the featured early career clinical trialist on the operations committee.
“People living in rural or remote communities in Quebec, as well as under-represented populations, will be able to participate in clinical trials – many of them for the first time – through the efforts of this new consortium,” says Dr. Louise Pilote. “With the ACT consortium, we want to involve more diverse participants in clinical trials, as well as embed research within community hospitals, in regions that don’t usually have the opportunity to participate in clinical trials.”
Funded with a total of $39 million dollars over three years, ACT brings together hundreds of researchers from 28 networks, 11 trial units from Nova Scotia to British Columbia and Nunavut, as well as patient-partners, 20 hospitals, and industry partners.
For more information on ACT, see Appendix 2 below.
New clinical trials to evaluate medical interventions in disease and infection
Several RI-MUHC researchers were awarded funding for specific clinical trials, totalling $4.5 million over 3 years. Dr. Maryam Oskoui will lead a trial to promote physical activity in children and adolescents with spinal muscular atrophy. Dr. Todd C. Lee will lead the Canadian arm of an international study to identify the most effective treatments for bloodstream infections caused by the bacterium Staphylococcus aureus. Dr. John Mitchell, who is also a co-investigator for the ACT consortium, will study the safety and efficacy of a drug to reduce pain in individuals with the metabolic diseases known as mucopolysaccharidoses.
“The Research Institute of the McGill University Health Centre is embedded within one of the largest and most modern academic health networks in North America. With our extensive resources and skilled personnel, we are well positioned to develop and conduct the highest quality clinical trials, which are vital to improving the health of people all across Canada,” says Dr. Rhian Touyz, executive director and chief scientific officer at the RI-MUHC. “I am especially proud that the RI-MUHC is playing a major leadership role in the multi-million dollar clinical trials CIHR grant scheme- in leading CANTRAIN, partnering with the pan-Canadian consortium ACT and successful funding for new clinical trials. I thank all the participants who make these successes a possibility, and I heartily congratulate the clinical research professionals involved in these important new projects which will positively impact patients of all ages and from all walks of life.”
CANTRAIN national project will increase Canada’s capacity to train personnel conducting clinical trials
Randomized clinical trials (RCT) aim to find out if promising approaches to disease prevention, diagnosis and treatment work in humans, outside of a laboratory setting. RCT have two or more groups of participants that receive different medical interventions (for example, a placebo, a new medical device, a new drug or vaccine, alone or atop an existing standard treatment). In a blinded RCT, the group to which each participant belongs is hidden until the end of the trial. These methods are used to avoid biases that could influence the results of a clinical trial.
Overall, a trial’s methodology, as well as the competency and efficiency of the many people involved at different stages, are key to its success.
“CANTRAIN will cater to different learner profiles. Our goal is to enable all stakeholders—physicians, health and research professionals, students, patients and community partners—to exchange, participate and work together to operate and implement large decentralized clinical trials,” explains Dr. Bourbeau. “It will first focus on standardizing competency training for those already working in research-related roles. The next step is for those who wish to gain further expertise as well as those embarking on a new career trajectory in clinical trials, including new immigrants who want to use their expertise in healthcare or medical sciences, but cannot practice their former profession in Canada.”
Four training streams for everyone involved in clinical trials
CANTRAIN will develop a national learning management system (LMS). The platform will provide core training on the scientific development and regulatory oversight of clinical trials, highlighting the importance of patient engagement in clinical research, as well as principles of equity, diversity and inclusion (EDI), such as sex and gender-balanced analysis. It will include four training streams: Clinical trials & Regulatory affairs, for postgraduate students who desire to acquire competency into the conduct of RCT, Trial operations, for clinical research professionals, Trial design and analysis, for physicians and methodologists and Coalition partners, for patients, indigenous communities and all other stakeholders who can provide important input on many aspects of clinical trials.
Developing and expanding Canada’s best available training courses and strategies
To start, CANTRAIN will integrate, enhance and scale up two strong, already existing programs: The CRP training program from SickKids (University of Toronto) and the RI-MUHC’s Clinical and Regulatory Affairs Experience (C&RAE). CANTRAIN will also develop a graduate certificate in clinical trials at McGill University in collaboration with other universities, targeting learners who wish to design and lead trials, analyze results, and report findings. Finally, the consortium will build and connect existing patient-partner training strategies developed across the country.
“With CANTRAIN, we will refine and expand the best training strategies to develop and operate the finest randomized clinical trials,” says Dr. Bourbeau. “I am confident that this nationwide partnership brings together the necessary tools and assets to improve Canada’s leadership in clinical trials.”
The ‘CANadian Consortium of Clinical Trial TRAINing’’ (CANTRAIN) is primarily funded by the Canadian Institutes of Health Research (CIHR). It is composed of:
- 95 team members – principal applicants, co-applicants and collaborators -including knowledge users, patient partners and related organizations as leaders in equity, diversity and inclusion, across nine provinces,
- Up to 15 academic institutions and research institutes,
- 10 health authorities, health centres and hospitals,
- seven provincial governments’ clinical trial organizations,
- four national health-related charities/associations/Alliances,
- several Strategy for Patient-Oriented Research (SPOR) Support Units (such as patient engagement organizations and industry partners, which would co-fund internships with federal MITACS).
For more information and the complete list of consortium investigators, partners and collaborators, visit www.wecantrain.ca.
ACT Canada Consortium will target more equitable access and participation in clinical trials
People in rural or remote communities, as well as under-represented populations, do not always have the possibility to participate in clinical trials. The new national consortium called Accelerate Clinical Trials (ACT) aims to change that reality across Canada. As part of this initiative, an RI-MUHC team of researchers will focus on overcoming Quebec’s specific challenges in ensuring equitable access and participation in clinical trials.
“Traditionally, people in many parts of Quebec don’t get a chance to play a vital role in developing life-changing medical procedures and medications, and that must change,” says Dr. Louise Pilote, one of the co-leaders of the ACT consortium at the RI-MUHC.
“We must encourage and assist more people to find new clinical trials that they or their loved ones can join,” adds Dr. Sushmita Pamidi, a respirologist and scientist in the Translational Research in Respiratory Diseases Program at the RI-MUHC, who is also a co-investigator of ACT. “We must harmonize between hospitals to make it easier to get a trial going, while maintaining integrity. We also want to work on better representation of Canadians in trials such as indigenous people, members of the LGBTQ2 community, women, children and older adults, and typically underrepresented ethnicities so that the results of studies apply to more Canadians.”
One way to increase the positive impact of clinical trials is to make them easier to set up.
“We have so many unanswered questions in medicine, and there are many barriers to setting up a new trial to answer these vital questions,” notes Dr. Emily McDonald, an internist and RI-MUHC scientist who will join ACT’s operations committee. “The work of the ACT consortium will allow us to lower these barriers.”
RI-MUHC researchers also involved in ACT include Drs. Jean Bourbeau, Todd Lee, Rita Suri, Patricia Li, John Mitchell and Atul Verma, as well as Annette Majnemer, PhD.
For more information on Accelerate Clinical Trials (ACT) Canada consortium, please visit https://www.act-aec.ca.
About the Research Institute of the McGill University Health Centre
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and healthcare research centre. The institute, which is affiliated with the Faculty of Medicine of McGill University, is the research arm of the McGill University Health Centre (MUHC) – an academic health centre located in Montreal, Canada, that has a mandate to focus on complex care within its community. The RI-MUHC supports over 450 researchers and around 1,200 research trainees devoted to a broad spectrum of fundamental, clinical and health outcomes research at the Glen and the Montreal General Hospital sites of the MUHC. Its research facilities offer a dynamic multidisciplinary environment that fosters collaboration and leverages discovery aimed at improving the health of individual patients across their lifespan. The RI-MUHC is supported in part by the Fonds de recherche du Québec – Santé (FRQS). rimuhc.ca