Overview
Canadian Drug
Approval Process
Accomplishments
National Myeloma
Database
Collaborating
Centres
Overview
Real World Evidence (RWE) refers to data collected from actual clinical practice and everyday patient care, as opposed to the controlled settings of traditional clinical trials. This evidence is gathered from various sources, including electronic health records, patient registries, insurance claims, and patient-reported outcomes, and provides valuable insights into how treatments perform in real-world settings.
For the Canadian Myeloma Research Group (CMRG), RWE plays a crucial role in enhancing the understanding of how therapies for multiple myeloma work across diverse patient populations. By leveraging RWE, CMRG can assess long-term treatment outcomes, identify rare side effects, and study patient responses to therapies outside the constraints of clinical trials. This data allows researchers to bridge the gap between clinical research and actual clinical practice, ensuring that treatment strategies are continually optimized for the best patient care.
In addition, RWE helps shape healthcare policies, informs regulatory decisions, and supports the development of new treatment guidelines, ultimately driving improvements in patient outcomes. Through partnerships with healthcare providers, institutions, and industry, CMRG is committed to advancing RWE studies to contribute meaningful, real-world insights to the fight against multiple myeloma.
Canadian Drug Approval Process
In Canada, the drug approval process is primarily governed by Health Canada, which evaluates the safety, efficacy, and quality of new medications through rigorous clinical trials. However, Real World Evidence (RWE) is increasingly playing a pivotal role in complementing this traditional framework, especially in the post-approval phase.
While clinical trials are essential for understanding how a drug performs under controlled conditions, RWE offers insights into how medications work in broader, more diverse patient populations after the drug is already on the market. Here’s how RWE contributes to the Canadian approval and regulatory process:
Post-Market Surveillance:
After a drug is approved, RWE is used to monitor its safety and efficacy in real-world settings. This ongoing surveillance helps identify rare or long-term side effects that may not have been apparent during clinical trials.
Health Technology Assessment (HTA):
Organizations like CADTH utilize RWE to inform Health Technology Assessments, which guide provincial and territorial drug reimbursement decisions. This ensures that new therapies are not only effective but also offer value for the healthcare system.
Regulatory Decision-Making:
RWE can support regulatory decisions by providing additional data on the drug’s effectiveness in everyday clinical practice. For instance, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) may rely on RWE to reassess drug indications or expand the use of a drug to other patient populations based on real-world outcomes.
Bridging Evidence Gaps:
RWE can provide data where clinical trials are lacking, such as in specific patient subgroups (e.g., elderly, those with comorbidities). This allows regulators to make more informed decisions about a drug’s use in real-world scenarios.
Patient-Centric Insights:
RWE captures patient-reported outcomes, treatment adherence, and quality of life metrics, which are increasingly important to regulators. This data helps assess the practical benefits and risks of treatments, providing a more comprehensive view of their impact on patients’ daily lives.
As RWE continues to grow in importance, it helps enhance patient safety, improve drug access, and ensure that treatments remain effective in everyday medical practice across Canada
Accomplishments
National Myeloma Database Overview
The Canadian Myeloma Research Group National Database (CMRG-ND) is a vital tool for advancing real-world evidence (RWE) research in multiple myeloma. By capturing data from a broad spectrum of patients across Canada, the CMRG-ND allows for the analysis of real-world treatment practices, patient outcomes, and disease progression outside of controlled clinical trials. This data is critical in evaluating how therapies perform in diverse patient populations, including those with comorbidities, older age, or other factors that might exclude them from clinical trials.
The database gathers comprehensive patient information, including demographics, disease characteristics, treatment histories, and long-term outcomes, which helps researchers identify trends and patterns in care. This real-world evidence informs not only clinical practice but also regulatory and policy decisions, guiding the approval of new therapies and refining treatment guidelines. Through this platform, the CMRG-ND accelerates the generation of meaningful insights that directly impact patient care, contribute to personalized medicine, and shape future innovations in multiple myeloma treatment.
Collaborating Centres
The Canadian Myeloma Research Group National Database (CMRG-ND) is a vital tool for advancing real-world evidence (RWE) research in multiple myeloma. By capturing data from a broad spectrum of patients across Canada, the CMRG-ND allows for the analysis of real-world treatment practices, patient outcomes, and disease progression outside of controlled clinical trials. This data is critical in evaluating how therapies perform in diverse patient populations, including those with comorbidities, older age, or other factors that might exclude them from clinical trials.
The database gathers comprehensive patient information, including demographics, disease characteristics, treatment histories, and long-term outcomes, which helps researchers identify trends and patterns in care. This real-world evidence informs not only clinical practice but also regulatory and policy decisions, guiding the approval of new therapies and refining treatment guidelines. Through this platform, the CMRG-ND accelerates the generation of meaningful insights that directly impact patient care, contribute to personalized medicine, and shape future innovations in multiple myeloma treatment.
Participating Centres:
- Princess Margaret Cancer Centre, Toronto
- BC Cancer, Vancouver Centre
- Juravinski Cancer Centre, Hamilton
- Hôpital Maisonneuve-Rosemont, Montreal
- Jewish General Hospital, Montreal
- Cross Cancer Institute, Edmonton
- London Health Sciences Centre, London
- Saskatchewan Cancer Agency, Saskatoon
- QEII Health Sciences Centre, Halifax
This extensive network ensures a robust and collaborative approach to clinical trials and real-world evidence research, helping drive meaningful advancements in the treatment of multiple myeloma across Canada.