Two New Projects Successfully Authorized Within Seven Weeks Thanks to CATALIS QUEBEC’S FAST TRACK Evaluation Service
While the first-ever FAST TRACK evaluation service pilot project was successfully completed last December, CATALIS is proud to announce that two more clinical trials have now been approved in record time.
The second FAST TRACK evaluation service coordinated a Phase I oncology study on advanced solid tumours by the Boehringer Ingelheim Canada (BI Canada Ltd) pharmaceutical company. This study was also authorized in a record-setting time of seven weeks by the Centre de recherche du Centre hospitalier de l’Université de Montréal (CR-CHUM) research centre. As a result, the CR-CHUM has positioned itself as the fastest site in the world to have been activated.
During this same period, Novartis Canada’s Phase III NEOS study, which seeks to assess the efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis, was authorized within seven weeks by The Neuro (Montreal Neurological Institute-Hospital).
This is Novartis’ second success: its study on the effect of inclisiran on cardiovascular morbidity and mortality in patients with coronary heart disease was the subject of the first-ever FAST TRACK evaluation service pilot project.
In its pilot phase, CATALIS’ FAST TRACK evaluation service has made it possible to reduce a clinical trial’s approval time frame by nearly 75% for a third consecutive time.
CATALIS Quebec’s management team is very proud of these additional pilot projects’ outcomes. The collaboration and trust it has maintained with its partners throughout the process were the keys to successfully completing and implementing innovative methods to optimize the launch of clinical trials in Quebec and from which patients will benefit. The FAST TRACK evaluation service will continue to be piloted until the fall, in collaboration with pharmaceutical companies that are CATALIS members and 15 participating Quebec health and social services institutions.
Study on Advanced Solid Tumours Conducted at the CR-CHUM by BI Canada Ltd.
“The FAST TRACK process in Quebec has demonstrated a strong commitment to revolutionize the clinical trial start up process with the aim to accelerate clinical development and expedite access to innovative medicines for patients. Boehringer Ingelheim Canada Ltd. is excited to see the success of the Quebec-based FAST TRACK service, which is an important collaboration endeavor that places the province in a favorable position globally to attract clinical research, and especially early clinical research.” – Gabriel Kim, Vice President, medical and regulatory affairs, Boehringer Ingelheim (Canada) Ltd.
“The CHUM is delighted with the success of the FAST TRACK clinical trial evaluation service. This dynamic approach strengthens Quebec’s international positioning and competitiveness in this field, especially that of the CHUM. In the future, more Quebecers will have access to the development of promising and innovative treatments. – Dr. Vincent Poitout, Director of Research at the CHUM and Scientific Director of the CRCHUM
” I am delighted that the close collaboration between CATALIS, the CHUM and its Therapeutic Innovations Unit has led to the approval of this Phase I oncology study for advanced solid tumors within 7 weeks. Thanks to the FAST TRACK evaluation service, our cooperation will make it possible to offer Quebec patients an increasing number of clinical trials. This is a great step forward for the clinical research community in Quebec and elsewhere, and another step towards increasing the competitiveness of our province on an international scale. – Dr. Rahima Jamal, hemato-oncologist and director of the Therapeutic Innovations Unit at the CRCHUM
“The success of the CATALIS Network’s FAST TRACK program demonstrates that it is possible to foster rapid access to innovative, potentially life-saving treatments and improve patients’ quality of life, when there is a concerted effort by all stakeholders to think outside the box and work together to improve the health of communities. The Quebec Cancer Priority Coalition welcomes this significant opportunity to improve health outcomes for people living with cancer, particularly through a promising oncology and personalized medicine research pipeline. With the FAST TRACK program, Quebec is well positioned to create health value and become a leader in access to innovative treatments. We look forward to the expansion of this program to become the new standard in clinical trials for the benefit of all Quebecers.” – Eva Villalba, MBA, MSc, Executive Director, Quebec Cancer Coalition
Novartis Canada’s NEOS Study on Pediatric Multiple Sclerosis Conducted at The Neuro
“We are very pleased with our second experience using the CATALIS FAST TRACK process. Thanks to the great collaboration between all parties involved, we completed the site reviews and achieved approval for our Multiple Sclerosis (MS) trial in children and adolescents involving ofatumumab (Kesimpta TM) as one of the treatment arms in seven weeks. As a result, we were able to activate the trial at the Montreal Neurological Institute, the first Canadian site to be initiated, on May 13th. “- Linda Carpentier, Head of Trial Operations at Novartis Canada
“The success of CATALIS’ FAST TRACK program, which expedited, among others, the ethical review of Novartis’ clinical research project at The Neuro bodes well for the future progress of this approach, which aims to attract more clinical trials to Quebec and, more specifically, to The Neuro.” – Dr. Guy Rouleau, Director of The Neuro (Montreal Neurological Institute-Hospital)
“Adolescents diagnosed with multiple sclerosis (MS) have limited treatment options and few opportunities to participate in clinical research and potentially access new therapies, which is why I am very pleased that the Clinical Research Unit’s (CRU) first-ever pediatric trial was launched in record time thanks to CATALIS’ FAST TRACK evaluation service. The NEOS trial will compare the efficacy and safety of three standard adult treatments to determine which is best tolerated by, and most effective for, these young patients with MS.” – Dr. Myriam Lévesque-Roy, Neurologist on The Neuro’s MS team, Consulting Neurologist at the Montreal Children’s Hospital and Principal Investigator of the NEOS trial at the CRU at The Neuro
“The CATALIS FAST TRACK Evaluation Service was developed with care to involve and respect the roles and functions of all stakeholders in the implementation of clinical trials. As a result, Quebecers can have quick access to quality clinical trials that are of potential benefit to them, while guaranteeing the independence of the Research Ethics Board and enabling it to be more efficient. – Vincent Lajoie, Co-Chair MUHC REB
“The Multiple Sclerosis Society of Canada is delighted with this study, which was accelerated through the CATALIS network’s FAST TRACK program. Supporting MS research is crucial, as it will lead to the discovery of new therapeutic targets and also have a direct impact on the quality of life of people living with MS. In Canada, MS is the most common neurological disease in young adults. Therefore, it is vital to support experienced Canadian scientists who are stepping up their efforts to better understand this disease and find effective ways to treat its symptoms and slow its progress. The FAST TRACK program, the driving force behind this study, is enabling local researchers to make significant breakthroughs which will benefit people across the country.” – Louis Adam, President, Atlantic and Quebec divisions of the Multiple Sclerosis Society of Canada
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