Clinical Research as a Care Option: Why the Lines Are Blurring — and Why That Matters
- Jane Abad
- Jan 19
- 5 min read
Updated: Jan 21
By: Heather DiFruscia, Vice President, Business Development & Growth, Sciteline
Date: January 19, 2025
Access to timely, evidence-based care across Canada is under increasing strain. Physician waitlists continue to grow, and many people face barriers to seeing specialists, receiving timely diagnoses, or accessing appropriate treatments. New data from the Ontario Medical Association indicate that more than 2.5 million Ontarians currently do not have access to a regular family physician, highlighting the ongoing complexity many patients face when navigating the health system [1]. In Ontario, recent reporting highlights encouraging progress in primary-care attachment, even as challenges persist for patients seeking consistent, ongoing care.
At the same time, patients and caregivers reasonably expect that the care they receive is informed by strong clinical evidence. In practice, access to care and evidence generation are closely connected. When patients experience barriers to care, gaps in evidence persist for many conditions and populations. These challenges are further compounded by delays in the availability of new therapies: according to Innovative Medicines Canada, only 21% of new medicines launched globally are available through Canada’s public drug plans, and it takes an average of three years from Health Canada approval for those medicines to become publicly accessible [2].
In this context, clinical research cannot be viewed as something conducted in isolation or confined to academic settings. Increasingly, it functions as a care option—a pathway through which patients may access clinical expertise, diagnostics, and therapies that might not otherwise be available.
This shift reflects real progress in how medicine is practiced. But as the line between research and care continues to blur, it also raises important ethical, operational, and equity questions. Doing this well requires more than speed or innovation; it requires intentionality.
Why Research and Care Are Converging
Research Is Embedded in Routine Care
Health systems are increasingly adopting learning health system models, where evidence is generated at the same time care is delivered. Pragmatic trials, platform studies, and real-world evidence approaches are designed to fit within everyday clinical workflows rather than operate separately from them.
For patients, this can mean participating in a study in the same clinic, with the same clinicians, as their usual care. This integration accelerates evidence generation and expands access—but it also changes how research is experienced.
Precision Medicine Depends on Research Access
Many advanced diagnostics and targeted therapies are not yet broadly funded or accessible through standard care pathways. For some patients, enrolling in a study is the only realistic way to access molecular testing, personalized treatments, or novel interventions.
As trials become more biomarker-driven and clinically aligned, research increasingly feels like a logical extension of care rather than an alternative to it.
Patients Are Looking for Options
When waitlists are long and care pathways are uncertain, patients naturally look for options. Clinical trials—interventional, observational, pragmatic, or decentralized—can offer:
• Earlier access to care pathways
• More frequent monitoring
• Multidisciplinary expertise
• Opportunities to contribute to evidence that improves future care
When access to care is constrained, access to research becomes a matter of health equity.
The Ethical Tension: Hope, Expectations, and Consent
As research becomes embedded in care, many patients arrive expecting treatment rather than uncertainty. That expectation is understandable—but it carries risk.
When patients believe a study’s primary purpose is to benefit them individually, this can lead to therapeutic misconception. The goal of a clinical trial is to answer a scientific question. Benefit may occur, but it is never guaranteed.
The alternative is therapeutic optimism—hope grounded in clear, honest communication. Hope is not the problem; false certainty is.
This makes consent more—not less—important. Consent is no longer a one-time administrative task; it is an ongoing conversation that must account for:
• What the patient already understands
• Their emotional readiness
• Their lived experience and personal constraints
Consent is not persuasion. It is partnership.
These reflections echo themes raised during a recent fireside chat at the Clinical Trials Ontario 2025 Clinical Trials Conference, where Maureen Smith, a member of CTO’s College of Lived Experience, and Dean A. Tripp, Chair of Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board, explored what it means to communicate ethically and clearly across the increasingly blurred lines between research and care.
Speed Matters — But Not at the Expense of Safety
Across Canada and globally, there is growing agreement that speed and safety are not competing goals.
The World Health Organization’s guidance and Global Action Plan emphasize that research should be treated as a core health-system function. Predictable, high-quality governance reduces duplication, lowers risk, and strengthens public trust—especially as research becomes part of routine care.
In Canada, this thinking is increasingly reflected in system-level reforms. Initiatives such as Clinical Trials Ontario’s Stream approach and CanReview are designed to deliver faster, more predictable start-up timelines without weakening safeguards.
CanReview’s single-REB model, for example, establishes:
• One Research Ethics Board of record for multi-jurisdictional studies
• Predictable timelines (28 business days for Canada-wide review, and 7 for additional sites)
• One submission, one approval, after which additional sites can join efficiently
Importantly, the approach is grounded in the principle that efficiency and quality reinforce one another. Boards reviewing on behalf of multiple institutions are designed to apply robust, consistent scrutiny, and operate within a growing community of practice that supports harmonization, transparency, and quality improvement.
The consistent goal across these efforts is to enable timely research without compromising safety—by strengthening governance, not bypassing it.
Inclusion and Equity: Who Gets Research-as-Care?
As research becomes a care option, longstanding exclusions become harder to justify.
Discussions across Canada have highlighted how populations such as people living with chronic kidney disease, pregnant or lactating individuals, and those of childbearing potential are often excluded by default. This leaves critical gaps in the evidence that informs everyday clinical decisions.
When care is assumed to be evidence-based but evidence is missing because research was never conducted, exclusion itself becomes a form of harm.
Efforts such as ACT 2.0, Indigenous-led research initiatives, and emerging guidance on proportionate consent models reflect a growing recognition that inclusion, governance, and ethics must evolve alongside trial design.
If research is truly a care option, equitable access to participation is not optional—it is foundational.
The Bottom Line: Research as Care Works Only If We Do It Right
The convergence of clinical research and clinical care is not a problem—it is progress. It expands access, accelerates innovation, and reflects how modern medicine operates.
But it also raises the bar.
When research becomes part of care, patients need:
• Transparent information
• Realistic expectations
• Time to understand
• Emotional and social support
• Clinicians and research teams who listen first
Predictable governance, meaningful consent, inclusive design, and strong ethical oversight are not administrative details, but foundational to high-quality care.
Doing this right means holding space for scientific progress and the lived experience of the people we serve. A comment shared at a recent conference captured how many within the clinical research ecosystem feel (researchers included): “We like researchers—but we like patients more.”
This piece reflects insights shared across recent Canadian clinical research discussions, including patient-partner and ethics leadership perspectives highlighted at the CTO 2025 Clinical Trials Conference, alongside publicly available system-level reporting.
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