Big Questions About Big Data

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Wednesday, May 29, 2019
Matrix Hotel, Edmonton, AB

Until fairly recently, the only ‘big data’ applications we saw were from established data linkage groups which had solid policies and procedures for ensuring ethical conduct. Increasingly, we are seeing a range of new developments – researchers working outside those large groups who want to link their own small research or clinical data with public population datasets and private sector clinical research organisations (CROs), pharmaceutical companies and device manufacturers who want to link their own data with other public and private population datasets. Outside of the health sector, educational and social care organisations are also discovering that data linkage can facilitate rigorous evaluations of their own programs.

Join Prof Annette Braunack-Mayer for an engaging talk on the social and ethical issues related to the collection and use of real world data to inform private and public health and social care decisions. Prof Braunack-Mayer will describe some of her current projects about these issues and the challenges they perceive for the future and the policy environment around data linkage.


Prof Annette Braunack-Mayer profile pictureProf Annette Braunack-Mayer, Head of School, School of Health and Society, Faculty of Social Sciences, University of Wollongong

Prof Braunack-Mayer is a bioethicist and public health researcher. Her research combines ethical analysis with a wide range of qualitative methods for engaging with citizens, patients, consumers and stakeholders. She has particular expertise in the use of deliberative methods of engagement with communities, but her research skill set extends across qualitative research and includes the incorporation of insights from quantitative research. She has led community engagement activities with citizens, patients and stakeholders across 10 funded projects, combining methods including citizens’ juries, in-depth interviews, focus groups, participant and non-participant observation, document and media analysis. Her current research spans vaccination policy and programs, the appropriate use of big data, obesity prevention, and chronic disease prevention in Aboriginal and Torres Strait Islander communities.

Event Details

Date: Wednesday, May 29, 2019
Time: 12:00 p.m. – 1:30 p.m. MT
Venue: Amber Room, Matrix Hotel
Location: 10640 – 100 Ave NW, Edmonton (Map link)

Please note: A light lunch will be served at this event.


Registration is required as seating is limited. To register, please click the following link:

Real World Evidence in Alberta NOAHE Event

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Presented by Alberta RWE and NOAHE. Dr. Scott Klarenbach will be speaking about the importance of Real World Evidence (RWE), how the province of Alberta has advantages with respect to utilizing Real World Evidence to facilitate cutting edge research and development, and how the Alberta RWE Consortium will help the province become a global leader in Real World Evidence generation.


Dr. Scott Klarenbach is a nephrologist and Professor in the Department of Medicine at the University of Alberta. He holds the Kidney Health Research Chair, and is the Chair of the Alberta Expert Committee on Drug Evaluation and Therapeutics, Chair of the Canadian Society of Nephrology Clinical Practice Guideline Committee, President of the Canadian Organ Replacement Registry Board, and serves on the Canadian Task Force on Preventative Health Care. He received his medical training at the University of Alberta, and completed his MSc in Health Economics at the University of York, United Kingdom. His research interests include health outcomes and health economics research; he has conducted numerous economic evaluations and health technology assessments for both chronic and acute conditions.

Event Details

Date: Thursday, January 17, 2019
Time: 12:00 pm – 1:00 pm MT
Location: Room 20D, ATB Place, 10020 – 100 St, Edmonton (Map link)

Please click the following link for more information about this event:

RWE Workshop Summary Report

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This report provides a summary of a real-world evidence (RWE) design sprint workshop that took place on October 21, 2018 in Toronto, Ontario. The workshop was developed and delivered as a joint partnership between the Canadian Agency for Drugs and Technologies in Health (CADTH); Canadian Association for Population Therapeutics (CAPT), Health Canada, and the Institute of Health Economics (IHE). The intent of the workshop was to identify key opportunities for RWE to support decision-making throughout the pharmaceutical product life cycle, as well as the evidence standards required to be considered decision-grade.

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.

DIA Real World Evidence Conference

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Within the past few years there has been a lot of discussion on the generation and utilization of real world evidence (RWE). It is well-known that regulators use RWE to monitor post-market safety and to make regulatory decisions, Sponsors utilize it to support both clinical trial design and observational studies to generate treatment approaches, and healthcare systems collect and use RWE to substantiate coverage decisions. However, what are the ‘new and innovative’ RWE applications in today’s healthcare ecosystem? This conference will explore examples of unique applications of RWE, and describe novel ways stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.

Please click the following link for more information:

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.

National Academies of Sciences, Engineering, and Medicine RWE Workshops

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On September 19–20, 2017, the National Academies of Sciences, Engineering, and Medicine held the first workshop of a three-part series titled Examining the Impact of Real-World Evidence on Medical Product Development. The workshops are intended to advance discussions and common knowledge among key stakeholders about complex issues relating to the generation and use of real-world evidence (RWE). The first workshop focused on how to align incentives to support the collection and use of RWE in health product review, payment, and delivery and how to address the barriers that impede the uptake and application of RWE. This publication briefly summarizes the presentations and discussions from the workshop.

On March 6–7, 2018, the National Academies of Sciences, Engineering, and Medicine held the second workshop of a three-part series titled Examining the Impact of Real-World Evidence on Medical Product Development. The workshops are intended to advance discussions and common knowledge among key stakeholders about complex issues relating to the generation and use of real-world evidence (RWE). The second workshop focused on practical approaches for the collection of real-world data (RWD)—data generated outside of the traditional clinical trial setting—and the use of RWE. This publication summarizes the presentations and discussions from this second workshop.

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.

International Population Data Linkage Network (IPDLN) Conference 2018

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The 2018 IPDLN Conference will be held at the Banff Centre, located in Banff National Park in Alberta, Canada. The conference will take place September 12-14, with a pre-conference day September 11. The theme is:  Linking Data – Improving Lives.  This event will create a forum for the presentation and discussion of research and innovation in the area of Linked Population Data Science and Policy Impact. The overall themes build on previous work done by IPDLN as well as relevant emerging health data linkage areas such as such as data and linkage quality, data linkage methodology, pan-jurisdictional and cross-sectoral data linkage, emerging data types, privacy, regulation and governance, data analytics, and data linkage for policy development.  More information can be found here.