Update on Bill 5: New Tools Available for Health Institutions 

As part of its government mandate to optimize the clinical research environment in Quebec, CATALIS supports provincial efforts that focus on the implementation of the Bill 5 on health and social services information (AHSSI or Bill 5). Its objective is to facilitate effective access to health information for research purposes to accelerate the development of innovative treatments for the well-being of Quebec patients.

The CATALIS Network’s Recommendations Following a Consultative Approach

In March 2024, CATALIS carried out consultations with health and social services institutions (HSSIs) to better understand the issues related to access to health information (HI) for research under Bill 25. Following these consultations, we submitted a report with recommendations and an action plan to the government with the aim of optimising access to HI under the AHSSI, while ensuring continuous improvement of processes based on automated provincial performance indicators.

Flow charts were also created to map the various paths of access requests according to the type of researcher. Province-wide shared tools, such as templates for Privacy Impact Assessment (PIA) forms, PIA Reports, and Health Information Access Agreements, have been developed by a working group of the health and social services network (HSSN) to facilitate this approach to accessing health information.

The Network’s Continued Involvement Through New Advisory Committees 

To ensure the successful implementation of the ARHSSI, two new advisory committees have been created to strengthen the involvement and mobilization of the CATALIS Network's public-private experts: the HSSN Data Advisory Committee and the Private Sector Data Advisory Committee.

The CATALIS Network's public and private members are committed to promoting an effective and innovative clinical research environment, including through optimized and monitored access to provincial health information, for the well-being of Quebec patients.

Learn More About the New Provincial Tools

The CATALIS Network continues to grow and collaborate to accelerate clinical research in Quebec. We proudly announce that five new health and social services institutions (HSSIs) will soon offer the FAST TRACK Evaluation Service. The CISSS de Lanaudière, the CISSS des Laurentides, the CISSS de Laval, the CISSS de l'Outaouais, and the CIUSSS du Centre-Sud-de-l'Île-de-Montréal have joined the fifteen institutions that have been offering this Service since 2022, which aims to accelerate the launch of clinical trials in Quebec.

Each new HSSI that joins the FAST TRACK Evaluation Service represents a new opportunity to accelerate clinical research and optimize collaborations between healthcare stakeholders in Quebec. These strategic partnerships are helping to position Quebec as an undisputed leader in health innovation while accelerating the development of innovative treatments for the province's patients.

The CHUM Authorizes a Novartis Study on Prostate Cancer and Recruits the First Patient Worldwide 

Novartis used the FAST TRACK Evaluation Service for its phase III study, PSMA-DC, which aims to assess the efficacy and safety of lutetium vipivotide tetraxetan (AAA617) in patients whose prostate cancer has advanced to an oligometastatic stage despite treating the primary tumour.

Dr. Cynthia Ménard at the Centre hospitalier de l’Université de Montréal (CHUM) and Dr. Mohammad Tamim Niazi at the Jewish General Hospital (JGH) took part in this study. The CHUM was the first site to start the trial and received approval in 9.4 weeks. This made it the first site to be activated in Canada, the 6th site worldwide and the first to recruit a patient in this study worldwide. This positioned it ahead of 125 other sites in 26 countries.

The JGH also authorized this study in 8.8 weeks, positioning it as the 2nd site activated in Canada and the 7th one worldwide.

The CHU de Québec-Université Laval Recruits

the First Two Participants Worldwide for a Clinical

Trial on Breast Cancer by Roche

The research team led by the CHU de Québec-Université Laval's Dr. Julie Lemieux recently recruited the first two participants worldwide for a phase III breast cancer study. With the support of CATALIS' FAST TRACK Evaluation Service, the health institution authorized and activated the Roche pharmaceutical company's pionERA study in a record time of 10.2 weeks. The CHU de Québec was, therefore, the fourth site activated worldwide out of the 300 sites in 30 countries where this study is being conducted.

Roche’s pionERA study is assessing a promising new treatment, giredestrant, which could overcome resistance to endocrine therapies, prolong patients' lives, reduce the risk of recurrence, and improve patient tolerability and quality of life. The study aims to recruit 1,050 people worldwide, including 30 patients in Quebec.

Montreal’s Jewish General Hospital Authorized the First BMS Study in 8.6 Weeks and Is the Most Rapidly Activated Site in Canada

The Bristol Mayers Squibb (BMS) pharmaceutical company used the FAST TRACK Evaluation Service for the first time, which led to the Jewish General Hospital’s Dr. Sarit Assouline’s research team to obtain authorization for the CA235-0001 study in a record time of 8.6 weeks. The JGH was the first site activated in Canada and the second one worldwide for this phase I study assessing a treatment for acute myeloid leukemia and myelodysplastic syndrome.

The treatment being studied, BMS-986497, targets leukaemia cells and could offer greater anti-tumour efficacy than standard treatments. It represents new hope for treatment and the possibility of improving the quality of life of affected patients who can no longer receive standard treatments. The study aims to recruit 35 participants worldwide, including 5 at the JGH.

The Amgen Pharmaceutical Company Joins the CATALIS Network 

CATALIS is pleased to welcome the Amgen pharmaceutical company to its Network of Partners.This biotechnology industry pioneer is dedicated to developing new treatments for various conditions, including rare diseases.

Amgen joins the many industry partners who are involved in the Network: Abbvie, Alexion, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences Canada Inc., GSK, Lilly Canada, Merck, Novartis, Novo Nordisk Canada Inc., Pfizer, Roche, Sanofi, Takeda, and Vertex.

These pharmaceutical partners support CATALIS in its mission to optimize clinical research in Quebec to accelerate the development of innovative care for the benefit of the province’s patients.

3 New Patient Organizations Join the CATALIS Network

We are pleased to announce that three new organizations have joined the CATALIS Network: The Canadian Association of Paroxysmal Nocturnal Haemoglobinuria (PNH) Patients, Crohn’s and Colitis Canada, and Pulmonary Hypertension Association Canada (PHA). These new members join the more than thirty patient-partner organizations currently involved in our Network. 

The CATALIS Network is committed to optimizing clinical research in Quebec to accelerate the development of innovative patient care for everyone’s benefit. Integrating these new organizations will increase our ability to represent patients’ voices and cover a wider range of medical conditions, expertise, and experiences in the service of clinical research.   

CATALIS Quebec ATALIS Quebec Partners With N2 Canada to Offer a Membership for 2024-2025 to Health and Social Services Network Institutions

CATALIS Quebec is proud to announce the renewal of its partnership with N2 Canada for 2024-2025. Through this partnership, CATALIS Quebec has committed to supporting the 2024-2025 membership of the health and social services institutions (HSSIs) which are part of the Health and Social Services Network (Réseau de la santé et des services sociaux) members of the CATALIS Network, to strengthen the skills of clinical research professionals across the province.

n keeping with the recommendations of the more than 45 public and private members of CATALIS’ Quality and Training Advisory Committee, this initiative aims to improve clinical research practices in Quebec while ensuring they align with pan-Canadian best practices.

N2 Canada membership includes: a clinical research education, an access to N2’s standard operating procedures (SOPs), and a Pan-Canadian educational activities.

One year ago, we launched Clinical Trials Quebec (CTQ), a provincial tool designed to provide complete and accessible information on clinical trials for everyone. 

The result of a collaborative effort of the CATALIS Network and developed in partnership with the Quebec government, CTQ is a hub of free and innovative information and services in clinical research that facilitates access to clinical trials for the Quebec population.  

We are proud of what we collectively achieved! We would like to thank all the partners who have made this project possible: the ministère de la Santé et des Services sociaux du Québec (MSSS), the ministère de l'Économie, de l'Innovation et de l'Énergie (MEIE), Health Canada, the Institut national d'excellence en santé et en services sociaux (INESSS), the institutions of the Quebec healthcare network, the patient associations and patient partners, and all the private members of the CATALIS Network!