
Speaker Biographies
Educational Presentations
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Educational Presentations
Over four days, ten educational presentations were given by seventeen experts covering a range of topics including Pragmatic RCT study design, statistics, ethics, equality, diversity, and inclusion (EDI), as well as practical experiences learned from conducting pragmatic trials.
Dr. Ahmed Al-Jaishi
Randomization with a focus on covariant constrained randomization
Dr. Ahmed Al-Jaishi is a Senior Epidemiologist with the Public Health Agency of Canada (PHAC). He received his PhD in Health Research Methodology from McMaster University, MSc in Epidemiology and Biostatistics from Western University, and BSc in Biological Sciences from the University of Guelph. His doctoral and post-doctoral research (funded by the Canadian Institutes of Health Research) addressed methodological challenges around conducting registry-based cluster randomized clinical trials in the hemodialysis setting.
Most of Dr. Al-Jaishi’s research leverages administrative healthcare databases to improve the delivery of best practices and health outcomes of patients on dialysis. Before joining PHAC, he worked with the ICES Kidney, Dialysis & Transplantation (KDT) Program for ten years as a trainee and ICES analyst, leading the vascular access file of the program.
As a PhD trainee, Dr. Al-Jaishi’s work at ICES KDT also focused on developing methodological and clinical expertise to perform high-quality research in renal disease and the methodology of randomized cluster trials. Dr. Al-Jaishi has been presented with many national awards for his work in as a trainee, including CIHR Doctoral and post-doctoral Awards, and authored numerous publications using ICES data. Dr. Al-Jaishi also held a pivotal role in the development and conducting of the MyTEMP Dialysate Trial, from its inception in 2014 to its final publication late last year.
Ms. Mary Beaucage
Ethics Presentation: The Ottawa Statement implementation guidance document for CRTs in the HemoDialysis setting (OSimple-HD): ethics guidance for researchers and research ethics committees co-developed with patient partners
Mary Beaucage is Anishnaabe, from Nipissing First Nation, near North Bay Ontario. She spent her career working in Retail Management, honing her skills in hiring, coaching, and succession planning, as well as opening new stores, analyzing markets and business needs. She is a vulnerable and engaging storyteller who trusts you with her story.
Ms. Beaucage has Type-2 diabetes and was diagnosed with end-stage kidney disease in 2013, for which she received dialysis. In March 2015, she received a kidney from her cousin Janice, who lives in Manitoba. She has been active as a patient research partner, consultant and advocate since 2016 including roles with Can-SOLVE CKD, CDTRP, Ontario Renal Network, Trillium Gift of Life, and the Transplant Ambassador Program.

Mr. Charles Cook
Ethics Presentation: The Ottawa Statement implementation guidance document for CRTs in the HemoDialysis setting (OSimple-HD): ethics guidance for researchers and research ethics committees co-developed with patient partners
Charles Cook was born and raised in the great state of Georgia, USA. He is the father of two fantastic young adults and is married to his wife Monica, who he refers to as “his rock.” Mr. Cook moved to Canada in the summer of 2006, landing in the Kitchener-Waterloo area of Ontario, and has been there ever since.
He is a two-time deceased-donor transplant recipient, having received a heart in 2016 and a kidney in 2017 at Toronto General Hospital. Having received two Gifts of Life, he strives to do whatever he can to pay those gifts forward because he knows that he can never pay them back. To this end, he shares the story of his journey and lessons learned whenever and wherever he can with the hope of benefiting patients coming along behind him.

Mr. Cook volunteers with several organizations, including the Kidney Foundation of Canada, the Transplant Ambassador Program, Can-SOLVE CKD, CDTRP and the ACB Organ Health YT Channel.
Dr. Laura Dember
Equity, Diversity and Inclusion – Where do Pragmatic Trials Fit In?
Lessons learned from conducting major trials
Dr. Laura Dember is a nephrologist and Professor of Medicine and Epidemiology at the University of Pennsylvania where she is a Senior Scholar in the Center for Clinical Epidemiology and Biostatistics and the Director of the Certificate Program in Clinical Research. She is a graduate of Yale University School of Medicine and completed her internal medicine residency at the University of Pennsylvania and nephrology fellowship at Penn and the Brigham and Women’s Hospital.
Dr. Dember conducts patient-oriented research in chronic kidney disease with a particular focus on interventions to improve clinical outcomes for patients treated with maintenance hemodialysis.

She has held leadership roles in several multicenter clinical trials and observational studies including the Dialysis Access Consortium, the Hemodialysis Fistula Maturation Study, the Hemodialysis Novel Therapies Consortium, the Chronic Renal Insufficiency Cohort study, and the HOPE Consortium trial, all funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). As the Principal Investigator for the NIH Time to Reduce Mortality in End-Stage Renal Disease trial (TiME), Dr. Dember played an important role in introducing to the Nephrology community large pragmatic trials embedded in clinical care delivery, an effort that she is continuing as a Co-Investigator for the NIDDK HiLo trial and as Multiple PI for the PCORI-funded SMaRRT-HD trial.
Presentation Slides
Dr. Steph Dixon
Statistics design for MyTEMP
Dr. Steph Dixon is a trained biostatistician and an ICES Scientist at ICES Western. She holds an adjunct Associate Faculty position in the Department of Mathematics and Statistics at the University of Guelph and adjunct Research Associate position in the Department of Epidemiology and Biostatistics at Western University.
Dr. Dixon’s research is supported by a multi-year grant from the Canadian Institutes of Health Research Strategy for Patient-Oriented Research – Innovative Clinical Trials. Over the past 10 years, Dr. Dixon’s efforts have focused on supporting research within KDT and for the Ontario Renal Network (ORN) – a key knowledge user of ICES. More recently, she has worked at ICES to build experience with routinely collected data and its applicability to trial work with a particular focus on developing/applying methods for the design and analysis of cluster randomization trials.
Dr. Dixon is the lead biostatistician for three large scale pragmatic cluster randomization trials (with design and follow up conducted with the routinely collected data at ICES) and key statistical/data consultant in several other ICES trials. She has co-chaired the ICES trials working group; participates in HDRN’s Canadian Data Platform Advisory Committee; and is contributing to the development of the Accelerating Clinical Trials (ACT) platform with Clinical Research in the Schulich School of Medicine and Dentistry at Western.
Dr. Sandra Eldridge
Practical experiences with Pragmatic Trials
Dr. Sandra Eldridge was Professor of Biostatistics and Director of the Pragmatic Clinical Trials Unit at Barts and The London School of Medicine and Dentistry until December 2021 and Associate Dean for Strategic Developments until December 2020. She has a degree in mathematics from Oxford University and an MSc in Medical Demography from the London School of Hygiene and Tropical Medicine.
Dr. Eldridge was the joint lead of the Centre for Primary Care and Public Health between 2007 and 2017 and a member of the Society for Academic Primary Care (SAPC) Executive between 2012 and 2017 and a member of the Royal Statistical Society Council between 2015 and 2019, and since 2015 has been an honorary member of the Royal College of General Practitioners.

Most of Dr. Eldridge’s research focuses on cluster randomized trials and complex interventions, particularly in primary care. Her research has resulted in a portfolio of influential peer-reviewed publications in this focus area, including extensive research funded by the National Institute of Health Research. In addition to her methodological research, while at Barts and the London School of Medicine and Dentistry, Dr. Eldridge held primary responsibility for the statistical design and analysis aspects of many collaborative research projects. Many of these projects involve cluster randomized trials.
Dr. Amit Garg
Implementation without coordinators for pragmatic trials/MyTEMP
Lessons learned from conducting major trials: the MyTEMP Trial
Dr. Amit Garg is the Associate Dean for Clinical Research, at the Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada. He is also a Professor of Medicine and Epidemiology & Biostatistics at Western University and an internationally recognized nephrologist and clinical scientist. Dr. Garg serves as a staff nephrologist with London Health Sciences Centre, Scientist with the Lawson Health Research Institute, and Scientist with ICES. He is the Site Director of the ICES Western facility, and Program Lead for the ICES Kidney, Dialysis & Transplantation Provincial Research Program (KDT).
In 2014, Dr. Garg was awarded the inaugural Dr. Adam Linton Chair in Kidney Health Analytics, and in 2021, he was awarded the Hellmuth Prize for Achievement in Research, Western University’s highest distinction for excellence in research.

Dr. Garg is a Past President of the Canadian Society of Nephrology and the Past Medical Lead for the Enhance Access to Kidney Transplantation and Living Donation Project with the Ontario Renal Network.
Most of Dr. Garg’s research and clinical work centers around ways to improve health outcomes for patients with chronic kidney disease and transplant. He has served as the primary investigator of several large, randomized trials, and his research has resulted in the publication of more than 680 articles in influential journals.
Presentation Slides
Dr. Cory Goldstein
Ethics Presentation: The Ottawa Statement implementation guidance document for CRTs in the HemoDialysis setting (OSimple-HD): ethics guidance for researchers and research ethics committees co-developed with patient partners
Dr. Cory Goldstein is a Postdoctoral Fellow with the Clinical Epidemiology Program at the Ottawa Hospital Research Institute and the School of Epidemiology and Public Health at the University of Ottawa. He received a BA in philosophy from McGill University, and an MA and PhD in philosophy from Western University.
Dr. Goldstein’s research centres on issues at the intersection of ethics and clinical trial designs with a focus on pragmatic randomized controlled trials that use innovative designs and electronic health records. He is currently working with an international team of ethicists, health providers, scientists, trialists, patient partners, and members of the public to co-develop and disseminate guidance for the ethical design and conduct of cluster randomized trials.
He is also leading the development of an ethics guidance document to assist researchers and research ethics committees in the design, conduct, and review of cluster randomized trials in the hemodialysis setting.

Dr. Areef Ishani
Practical experiences with Pragmatic Trials, RE: Platform trials in VA dialysis units
Dr. Areef Ishani is the Director of the Primary and Specialty Care Service Line at the Minneapolis VAHCS and the Director of Specialty Care for the Veterans Integrated Service Line. He received his medical degree from University of Toronto Faculty of Medicine and has been in practice for more than 20 years.
Dr. Ishani’s research centres on the use of large datasets to evaluate correlates of both acute and chronic kidney disease. He has conducted studies that evaluated the causes and outcomes associated with acute kidney injury, long-term outcomes of acute kidney injury following cardiac surgery, and the impact of physician payment on outcomes in patients on dialysis.
His research includes several randomized controlled trials held at the Minneapolis VAHCS, including the SPRINT trial and the VA Coop Study 597, The Diuretic Comparison Project (DCP), and has additional funding secured to conduct another VA Cooperative Study funded focused on comparing a dialyzable vs non-dialyzable beta blocker on cardiovascular outcomes.
Catherine Joyes
Western University’s Accelerating Randomized Trials (ART) Platform
Ms. Catherine Joyes is the Associate Director of Clinical Research at the Schulich School of Medicine & Dentistry at Western University. She provides operational oversight for the various initiatives within Schulich’s clinical research enterprise, including the advancement of its trials platform which includes pragmatic, First-in-Human, and standard trial streams.
Ms. Joyes has worked at Schulich since 2015. Prior to joining Schulich’s research department, she managed the secretariat of the Southwestern Academic Health Network (SWAHN). In this role, she contributed to its mission to improve health and health care delivery across Southwestern Ontario by connecting health care professionals, educators, and researchers in projects that integrated research, education, and clinical practice.
Ms. Joyes also worked for Western University from 1997 to 2002, as a member of the Prospect Research team in Advancement Services, part of the External Relations Department at Western. Between these different roles at Western, Catherine spent 12 years working for non-profit funding organizations managing community grant-making programs.
Ms. Joyes holds an HBA (History) from Brescia University College, a Master of Library and Information Science from Western University, and an Executive MBA from the Ivey School of Business. A life-long Londoner, Catherine has an affinity for continuous learning and development.
Dr. James Kaufman
Practical experiences with Pragmatic Trials, RE: Platform trials in VA dialysis units
Dr. James Kaufman is a Professor of Medicine in the Division of Nephrology at the New York University Grossman School of Medicine and a Staff Physician at the VA New York Harbor Healthcare System. He received his MD from the University of California, San Francisco School of Medicine, and completed his training in internal medicine and nephrology at the University of California, San Francisco, the University of Michigan and the Walter Reed Army Institute of Research.
Dr. Kaufman served the United States Veterans Affairs (VA) as Chair of the Renal Field Advisory Group, as a member of the Chronic Kidney Disease Clinical Practice Guidelines committee and the Merit Review Study Section for the Clinical Research Program, and as Chair of the VA Medical-Surgical Data Monitoring Committee.
He has served as chairperson for many major clinical trials in kidney disease, sponsored by the United States Veterans Affairs, the NIH and industry. These trials have been published in leading journals including the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of the American Society of Nephrology. Dr. Kaufman has authored 146 peer-reviewed publications. Furthermore, he is the co-chair of a VA pragmatic trial focused on determining the best beta-blocker to use in hemodialysis patients. He is also an Associate Editor of the American Journal of Kidney Disease.
Dr. Taylor McLinden
The HDRN Canada Pragmatic Trials Training Program
Dr. Taylor McLinden, PhD, is the Manager of the HDRN Canada Pragmatic Trials Training Program (coordinated by the Schulich School of Medicine and Dentistry, Western University).
He holds positions at ICES Western, HDRN Canada, and the London Health Sciences Centre. He also has an appointment as an Adjunct Research Professor in the Department of Epidemiology and Biostatistics at Western University. Previously, he was an Epidemiologist and Scientific Officer at the British Columbia Centre for Excellence in HIV/AIDS.
Prior to a postdoctoral fellowship in Vancouver, Dr. McLinden completed a PhD in Epidemiology at McGill University. He also earned a MSc (Epidemiology) from the University of Guelph and an Honours BSc (Biomedical Sciences) from Brock University.
Dr. Rona Smith
Lessons learned from conducting major trials, RE: The SIMPLIFIED Trial
Dr. Rona Smith is a senior research associate at the University of Cambridge, UK and an honorary consultant in nephrology and vasculitis at Cambridge University Hospitals NHS Foundation Trust. Her research focuses on later stage translational research and efficient clinical trials in the renal and immunology space. She is currently chief investigator on four national trials, including two pragmatic trials in dialysis patients – SIMPLIFIED and PHOSPHATE. These trials utilize routinely collected health care data via the UK renal registry and NHS digital, and also the national prioritized Covid-19 pre-exposure prophylaxis platform study, PROTECT-V, for vulnerable individuals.
Dr. Smith takes a truly collaborative approach to research, building links across traditional disciplinary barriers. She has developed many partnerships over recent years with clinicians and academics nationally and internationally, as well as with charitable organizations, the National Institute of Health and Research (NIHR), industry and patient groups.
She is also medical director of the Patient Led Research Hub (PLRH) in Cambridge, which is a unique organization in the UK which co-produces research with patient organizations addressing their own research questions.
Dr. Monica Taljaard
Introduction to Stepped Wedge Design
Ethics Presentation: The Ottawa Statement implementation guidance document for CRTs in the HemoDialysis setting (OSimple-HD): ethics guidance for researchers and research ethics committees co-developed with patient partners
Dr. Monica Taljaard is a Senior Scientist in the Clinical Epidemiology Program at the Ottawa Hospital Research Institute (OHRI) and a Professor in the School of Epidemiology and Public Health at the University of Ottawa. She received her PhD degree in Epidemiology and Biostatistics at Western University in 2006. Her main research interests are in the design, analysis and ethics of pragmatic and cluster randomized trials.
As a methodologist with the Ottawa Methods Centre, she works with clinicians and researchers from a variety of backgrounds in the design and analysis of their studies including clinical trials and observational studies. Dr. Taljaard has 400 publications in peer-reviewed journals. Furthermore, she has acted as principal investigator, co-investigator or collaborator on more than 180 funded peer-reviewed grants. She is Deputy Editor of Clinical Trials: Journal of the Society for Clinical Trials.
Dr. Myles Wolf
Lessons learned from conducting major trials, RE: The HiLo Trial
Dr. Myles Wolf is the Charles Johnson, MD, Distinguished Professor of Medicine and Chief of the Division of Nephrology at the Duke University School of Medicine. Dr. Wolf received his MD from the State University of New York – Downstate, completed internal medicine and nephrology training at the Massachusetts General Hospital, and obtained a MMSc degree in Clinical and Physiological Investigation from Harvard Medical School.
As Chief of Duke Nephrology, Dr. Wolf is also responsible for developing the vision and executing the operational strategy of Duke Nephrology across its clinical, research and educational missions.
The focus of Dr. Wolf’s clinical trials, patient-oriented, epidemiological and laboratory research is disordered mineral metabolism across the spectrum of kidney disease from early stages to end-stage renal disease and following kidney transplantation.
Since 2002, Dr. Wolf’s research has been supported by the American Heart Association, National Kidney Foundation, American Society of Nephrology, and National Institutes of Health. As Principal Investigator, he has been the recipient of more than $30 million of extramural grant support throughout his career.
Dr. Wolf currently leads “HiLo,” which is a randomized multicenter pragmatic clinical outcomes trial of phosphate management in more than 4000 patients with end-stage renal disease.
Dr. Charles Weijer
Ethics Presentation: The Ottawa Statement implementation guidance document for CRTs in the HemoDialysis setting (OSimple-HD): ethics guidance for researchers and research ethics committees co-developed with patient partners
Dr. Charles Weijer is a Professor of Medicine, Epidemiology and Biostatistics, and Philosophy at Western University. Dr. Weijer graduated from the University of Alberta’s Faculty of Medicine & Dentistry. He also holds an Honours BA, MSc, and PhD in Bioethics from McGill University.
Dr. Weijer is a leading expert on the ethics of randomized controlled trials. He co-led a collaboration that produced the first international ethics guidelines for cluster randomized trials. He led the writing team for the World Health Organization guidance on “Ethical Considerations for Health Policy and Systems Research.” Recently, he served on the WHO Working Group for Guidance on Human Challenge Studies in COVID-19.

At the moment, Dr. Weijer leads a team of 31 researchers across four continents working to update the Ottawa Statement for the Ethical Design and Conduct of Cluster Randomized Trials. This project, funded by the Canadian Institutes of Health Research, will update ethical guidance for cluster trials and produce implementation guidance documents for low- and middle-income countries and other settings. In 2014, he received Western’s Hellmuth Prize for Achievement in Research, and, in 2016, he was elected to the Royal Society of Canada.
Dr. Merrick Zwarenstein
What makes a trial pragmatic?
Dr. Merrick Zwarenstein is a Professor in the Departments of Family Medicine and Epidemiology and Biostatistics at Western University. He is a health services researcher focused on research methodology, specifically randomized trials of complex interventions in primary care. Dr. Zwarestein trained at the Karolinska Institute in Sweden (PhD), the London School of Hygiene in the UK (MSc in Community Health) and Witwatersrand University Medical School in South Africa (MD and MSc in Microbiology).
He leads collaborative research projects, bringing together partners from around the world to promote the conduct and use of health systems research, especially pragmatic randomized trials in healthcare decision-making.
He is the principal investigator for a network of Canadian health services and policy research focused on overcoming the limitations of randomized trials in support of policy decision-making. In addition to his support for the development of many research projects, Dr. Zwarenstein has also led the production of several research tools, including web-based training tools for randomized trials and widely used guidelines for the design and reporting of pragmatic randomized trials.
Furthermore, he developed new uses for Ontario’s administrative health databases for large-scale implementation and cluster randomized trial evaluation of quality-of-care interventions, resulting in some of the world’s largest randomized trials.