Department of Philosophy, Western University
Cory Goldstein is a doctoral student in philosophy at Western University. He received a B.A. in philosophy from McGill University (2014), and an M.A. in philosophy from Western University (2016). His philosophical interests are primarily in applied ethics, particularly the ethical design and conduct of medical research. He is currently working on two projects exploring the ethical issues of pragmatic randomized controlled trials. He enjoys travelling to and from Tim Horton’s to refuel on coffee, taking long walks on “concrete beach” outside of Western’s University Community Centre, and running from the geese on campus.
My doctoral project explores ethical questions raised by the use of renal dialysis facilities as a research platform for the conduct of pragmatic randomized controlled trials, specifically those that use electronic health records and innovative trial designs. These trials evaluate the adoption of medical treatment—e.g., longer dialysis times, different hemodialysis temperatures, or lower dialysate sodium concentration—as policy at participating dialysis facilities.
Some ethical questions may include the following: Given that the medical treatment in such studies could be evaluated with an individual randomized controlled trial, under what circumstances is the use of an innovative pragmatic design (e.g., stepped-wedge trial, or cluster-crossover trial) appropriate? Do patients and health providers have an ethical obligation to participate in pragmatic randomized controlled trials? From whom, how, and when is informed consent required? How can a waiver of consent be consistent with the notion of respect for persons? Who are the gatekeepers in pragmatic randomized controlled trials, and what are their responsibilities?
Currently, we lack a robust ethical framework for pragmatic randomized controlled trials. As a graduate research assistant, I work with two CIHR-funded research teams whose aim is to produce guidance for the ethical design and conduct of these trials. My doctoral project aims to provide a robust ethical framework to help facilitate the research teams’ overlapping goal.
Project Title: Developing a framework for the ethical design and conduct of pragmatic randomized controlled trials to improve the quality and value of health care systems and practices
Principal Investigators: Monica Taljaard, Dean Fergusson, Terry Klassen, Charles Weijer
Brief Description: Pragmatic randomized controlled trials (RCTs) can provide patients, doctors and policymakers with more reliable information as to which treatments and strategies are best for patients. But whilst ethical guidelines exist to protect participants in research, their applicability for pragmatic RCTs is not straightforward. This has led to confusion, where some trials have been carried out with inadequate protections, and in others, strict enforcement of current guidelines have posed unnecessary obstacles, undermining scientific quality and impeding improvements in the quality of healthcare. Our goal is to develop internationally accepted guidance for the ethical design and conduct of pragmatic RCTs.
Project Title: An integrated platform for innovative pragmatic cluster-randomized registry trials in hemodialysis
Principal Investigators: Amit Garg, Monica Taljaard, Charles Weijer
Brief Description: Hemodialysis is a life-sustaining treatment for patients whose kidneys have failed. However, quality of life is poor (worse than many advanced cancers), life expectancy is short (average three years), and associated healthcare costs are high (~$10,800 per patient per month). Our goal is to improve the experiences, outcomes, and healthcare of patients receiving hemodialysis. We will do this by leveraging our partnerships to bring together expertise and health data assets onto an integrated platform to conduct innovative pragmatic registry trials in hemodialysis, and to translate these comparative-effectiveness trials into better practice. We plan to embed large pragmatic randomized trials into routine hemodialysis care and make use of existing data-rich registries with linked healthcare data for almost all baseline and follow-up information. We can complete trials with the same quality and statistical power as the traditional approach, in less time and a lower per-patient cost.