A First Successful Pilot Project for CATALIS’ New FAST TRACK Evaluation Service: 4 Quebec Institutions Ranked in the Top 5 of the World’s Fastest Sites
CATALIS is very proud to announce that the first pilot of its new FAST TRACK assessment service has successfully reduced the approval time for an industry-financed clinical trial by almost 75%.
In September 2021, four Quebec health institutions (three of which are CATALIS members) piloted the new FAST TRACK evaluation service for the first time with a randomized, multi-centre study by Novartis Pharmaceuticals Canada inc. The participating institutions are the Research Institute of the McGill University Health Centre (RI-MUHC), the Université de Montréal Health Centre (CHUM), and the Université Laval Health Centre (CHU de Québec), which are the CATALIS members, and the Université Laval’s Quebec Heart and Lung Institute (IUCPQ-ULAVAL). This global study aims to assess the effect of Inclisiran on cardiovascular morbidity and mortality in patients with coronary heart disease.
Now that the evaluation process has ended, we are pleased to confirm that the MUHC, CHUM, and CHU de Québec have all authorized the project in 8 weeks. As such, they have positioned themselves in the top 3 of the world’s fastest sites, ahead of more than 1,000 other sites in more than 40 countries. The IUCPQ-ULAVAL also acted rather quickly, authorizing the project in 10 weeks, leading to a 5th place ranking in the world. We are proud to announce that, topping off this huge success, the CHU de Québec was the first site to recruit the first patient from a worldwide target of 15,000 patients expected to participate in this study.
In response to this announcement, Pierre Fitzgibbon, Quebec’s Minister of the Economy and Innovation, reacted very favourably. “The FAST TRACK evaluation service’s first pilot project is a tangible benefit resulting from our life sciences-focused efforts and our government’s strategy to attract more clinical trials and private investment to Quebec. The CATALIS network proves that it is possible to be innovative in a highly competitive international environment. We are proud to support its efforts to position Quebec on the world stage of clinical research,” he stated.
“I am very impressed by Quebec’s determination and the ability of the various stakeholders to work together to develop one of the most innovative clinical trial implementation models in the world. The speed and effectiveness of clinical trials are critical to addressing the urgent need for patients to be able to access lifesaving, innovative treatments. In the case of cardiovascular disease, this is a global issue that we are fighting,” said Christian Macher, Novartis Canada Country President. “I am delighted that Novartis was the first company to experience this new service, and I look forward to further collaboration with Quebec’s health institutions.”
Three Years of Effort Which Led to the FAST TRACK Evaluation Service
The process leading to establishing the FAST TRACK evaluation service began gradually with the creation of CATALIS, whose operations allowed for an in-depth discussion of the issues and solutions needed to accelerate the launch of clinical trials in Quebec. Beginning in 2018, the CATALIS network’s public and private experts met many times to develop revision standards and operational tools for use by the FAST TRACK evaluation service. In the past year, the network held more than 20 working groups specifically to identify the best operational approach for the service.
“To ensure patient safety, clinical trials must follow rigorous regulatory and ethical processes. From the outset, it was imperative that the FAST TRACK evaluation service meet these requirements in a high-performance environment,” said Marie Hirtle, Chair of the MUHC Research Ethics Board, which was responsible for the first pilot project’s ethics review. “The CATALIS network focused on developing the new service so that ethics committees could base their evaluation on a high-quality project application. With the use of functional templates from the sponsor that incorporate Quebec’s harmonized legal clauses, we can assess them much more quickly,” she added.
Dr. S. John Weisnagel, head researcher at CHU de Québec, said he was very encouraged by the province’s initiative in implementing a service that meets the needs of clinicians and patients. “This new service reduces the administrative burden on research teams. In addition, with the greater predictability offered by the approval system, we can identify and recruit subjects more quickly, allowing Quebec patients to participate in large-scale international clinical research projects, potentially bringing innovative treatments to market.”
CATALIS Quebec’s management is very proud of the culmination of this first pilot project and would like to commend its partners for their open-mindedness. They jumped on board without hesitation to take part in a rigorous process of reviewing processes that contrasts with the traditional way of doing things. “Our challenge now will be to sustain the service and maintain this excellent performance regardless of the volume of projects to be processed. With the addition of qualified and sufficient resources to ensure effective implementation, we are confident that we will meet this challenge,” stated Danika Laberge, General Manager of CATALIS Quebec.
In collaboration with CATALIS member pharmaceutical companies and over a dozen of Quebec’s health institutions, this project’s pilot phase will be carried out through the summer of 2022. Stay tuned: In January, CATALIS Quebec will be announcing the list of institutions which will be taking part in the FAST TRACK evaluation service’s pilot phase.
If you are a pharmaceutical company and would like more information about this service, please write to us at: email@example.com.