Consortium Updates

Biologics/Biosimilars Project Update

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A meeting of the Implementation Working Group took place on June 26, 2018. Alberta Health provided an update regarding their preliminary discussions with the pan-Canadian Pharmaceutical Alliance about potential opportunities to partner resources for a project in Alberta that could support provincial aspects of biosimilar implementation, as well as opportunities to leverage more broadly. At this time, Alberta Health is still considering options and approaches. With this, a decision has been jointly made by the Consortium and Alberta Health to withdraw biologics/biosimilars as a Consortium project. The IHE will revisit this work and the needed support with Alberta Health at a future date.

The Working Groups (Implementation and Data Monitoring) were established prior to the creation of the Alberta RWE Consortium, which eventually assumed leadership for the project and supported the Working Groups from a project management perspective. The Working Groups may still be of value to Alberta Health, and therefore may be convened for support when information can be shared on the funding, timing, focus, and deliverables. This activity will occur independently of the Consortium, and essentially reflect an earlier state prior to formation of the Consortium. Similarly, the Data Monitoring Working Group may be engaged at the appropriate time to understand what value-added support can be provided by that group in the context of ongoing clinically-led initiatives to establish monitoring metrics and platforms.

Second Annual Duke-Margolis Conference on Real-World Data and Evidence

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Convened by the Robert J. Margolis, MD, Center for Health Policy at Duke University, the Second Annual Duke-Margolis Conference on Real-World Data and Evidence will bring together top experts and speakers to examine topics related to the use of real-world data (RWD) and evidence (RWE) in drug development and regulatory decision-making. Workshop sessions will highlight takeaways from two new white papers that will be released in conjunction with this conference (titles to be finalized):

  • “Real-World Data Quality and Relevance: Characterizing Data for Regulatory Use” examines the process and factors that should be considered while characterizing RWD quality and relevancy for regulatory purposes
  • “Applying Credible Observational RWE to Regulatory Decisions” focuses on the process for determining the regulatory acceptability of observational studies.

In-person and webcast registration are now open, with limited in-person seating available.

More information here.


Alberta Data Asset Directory

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The Alberta RWE Consortium is pleased to make available an Alberta Health Data Asset Directory.  This resource has been prepared by the Consortium to provide interested organizations with an overview of the major data assets within the province. The identified assets are organized into three (3) different categories.

  1. Clinical (e.g. laboratory investigations, dispensed pharmaceuticals, immunizations)
  2. Populations & Health Resource Utilization (e.g. provincial client registry, hospital admissions, physician visits)
  3. Oncology (i.e., administrative and clinical data specific to oncology)

This Directory will be updated regularly as new assets become available or accessible. Some of the assets in this Directory have more limited access and documentation than others. For all potential RWE projects, research teams working under the leadership of the Consortium will conduct a feasibility assessment to confirm data availability and accessibility for specific requirements.

Alberta RWE Consortium Co-Chair Change

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The Secretariat of the Alberta RWE Consortium is pleased to announce that Dr. Scott Klarenbach (University of Alberta) and Dr. Fiona Clement (University of Calgary) will serve as co-Chairs representing their institutions. Dr. Christopher McCabe (Institute of Health Economics) will continue to serve as a co-Chair.  We thank Dr. Lawrence Richer (University of Alberta) and Dr. Marcello Tonelli (University of Calgary) for their strong contribution and leadership to help establish the Consortium.

Alberta health organizations and universities team up to optimize analysis of real world data to inform decision-making

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The Institute of Health Economics, the University of Alberta, and the University of Calgary are pleased to announce the creation of the Alberta Real World Evidence C onsortium – . The mandate of the Consortium is to support the development of quality real world evidence generation and utilization.

Real World Evidence (RWE) studies investigate the impact of an intervention or technology on health outcomes and resource utilization in clinical conditions outside of the controlled clinical trial setting. The evidence is generated from routinely collected health data to evaluate the safety, effectiveness, and value of newly introduced or existing health technologies and/or other interventions.

Alberta has one of the largest, most mature, detailed and comprehensive health system data depositories in Canada. As such, Alberta is poised to become a global leader in RWE generation. To realize this potential, the Universities of Alberta and Calgary, along with the Institute of Health Economics, have led the formation of the Alberta RWE Consortium. Consortium membership also includes Alberta Innovates, Alberta Health, Alberta Economic Development and Trade, and Alberta Health Services.

Alberta is a leader in health innovation. With Canada’s largest integrated health delivery system and this new consortium, we are set to take a leadership role in RWE research. The University of Alberta is excited to gain new insights to streamline and improve health care through real world data,” said Dr. Lawrence Richer, Associate Dean, Clinical & Translational Research, University of Alberta.

Through the Alberta RWE Consortium, industry and other health system partners have access to coordinated resources, expertise, processes, and data that ensures high-quality RWE studies.

Key functions of the Consortium include:

  1. Optimization of Alberta’s RWE studies
  2. Strengthening the Alberta RWE ecosystem
  3. Providing world class project support services, including study design, execution, and knowledge sharing
  4. Identifying and supporting projects that align with provincial health and policy priorities, ensuring relevance to decision-makers in Alberta
  5. Convening the best pan-provincial teams for commissioned, large-scale projects that may also have implementation components

The RWE consortium will help foster cutting-edge health research with industry and other health sector partners interested in real world data applications in Alberta,” said Dr. Marcello Tonelli, Associate Vice President, Research, University of Calgary, “This will guide health care investment, making policy more effective and impactful.

RWE is playing a growing role in technology adoption, as well as health policy and clinical practice decision-making, recognizing some of the limitations of traditional controlled clinical trials. Governments and health service providers are using RWE to improve health outcomes in priority areas, and to monitor the post-market safety and effectiveness of new or existing health technologies and innovations. This information is also being used to support coverage and procurement decisions, as well as to assess return-on-investment of public dollars. Additionally, clinicians are increasingly using this information in the development of clinical guidelines and decision-support tools, and, with quality RWE, technology developers may improve market access over time.

As a trusted convener, the Institute of Health Economics has a long-standing history of fostering collaborative partnerships. As Secretariat to the RWE consortium, the IHE will support the optimization of quality RWE research in Alberta,” said Dr. Christopher McCabe, Executive Director and CEO, Institute of Health Economics.

Albertans place a high value on their right to privacy and confidentiality. The province protects and controls health system data through a rigorous data-protection regulatory framework. Those working on Consortium-led projects (e.g., data custodians and researchers) are legally obligated to be in strict compliance with provincial and federal privacy legislation, as well as established organizational privacy and security policies. For more information about the Consortium, its suite of services, and its privacy and security measures, please visit

Jasmine Brown
Director of Communications, Institute of Health Economics
Office: (780) 401-1768 | Cell: (780) 966-4879 | Email: [email protected]

Shelby Soke Communications Associate
Faculty of Medicine & Dentistry, University of Alberta Office: (780) 492-0647 | Email: [email protected]

Jenny McLean
Communications and Marketing Specialist
Office of the Vice-President, University of Calgary
Office: (403) 210-3992 | Email: [email protected]