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Under the 2030 Vision, Research Priority 4 is accelerating investigator-led, innovative and inclusive clinical trials — strengthening The Institute’s role as a national leader in precision health

Clinical trials mark the moment when discovery becomes care — when years of laboratory research and data analysis reach patients and begin to transform clinical practice.

At the Research Institute of the ɬ﷬ Health Centre (The Institute), clinical trial excellence is not new. Investigators have long led high-impact studies across disciplines, contributing nationally and internationally to advances in patient care.

With the launch of its , that strength has become a coordinated strategic priority. Central to the plan is Research Priority 4: advancing clinical trials through novel methods to inform and improve patient care at all ages.

For , scientist at The Institute, co-chair of the and leader of Research Priority 4, that shift is about alignment.

“Clinical trials are complex,” she said. “When we align the right expertise, infrastructure and partnerships, we can accelerate innovation and deliver better care to patients.”

Expanding trial leadership

The Institute has been a leading site for industry-sponsored Phase II and III trials, contributing to major advances across disciplines.

The 2030 Vision builds on that foundation by increasing investigator-led and early Phase I trials to further strengthen clinical innovation at The Institute.

Phase I trials are often the first time a new therapy is tested in patients. They represent the true bench-to-bedside moment — where mechanistic discovery and clinical care converge.

“In Phase I trials, you’re defining something new,” said , Director of Clinical Research at the . “That’s where real innovation begins.”

Supported by the CIM, early-phase work continues to grow. Leaders such as Dr. Genge and , Medical Director for Oncology Clinical Trials at the CIM, are advancing Phase I capacity across The Institute.

Building the infrastructure: ACT-CTU

Expanding trial leadership requires coordination and operational strength.

Launched in October 2023, the brings investigators together around shared expertise while coordinating infrastructure and standardized processes that support the full lifecycle of clinical trials — building institutional capacity without duplicating existing efforts.

Dr. Pamidi co-chairs ACT-CTU alongside , senior scientist and Deputy Executive Director and Deputy Chief Scientific Officer, with operational coordination and implementation led by project manager Amanda Lovato.

Since its launch, ACT-CTU has:

  • Supported 51 clinical trials
  • Funded eight pilot trials through internal competitions
  • Established a Novel Trial Methods Hub
  • Expanded regulatory support, including dedicated Health Canada expertise

Together, these initiatives streamline processes, strengthen trial design expertise and make clinical trial infrastructure more accessible across The Institute.

A community of trialists

The growth of clinical trials at The Institute is grounded in longstanding expertise.

Senior investigators including , National Director of CIHR’s network; ; ; ; and provide national and international leadership in infectious diseases, clinical epidemiology and randomized trials.

Methodological expertise is equally strong at The Institute, with leaders such as , in biostatistics and epidemiology and , director of the Novel Trial Methods Hub, strengthening trial design capacity throughout The Institute.

“There’s tremendous expertise here,” Dr. Pilote said. “The opportunity is to connect it — and make it more accessible to the next generation of investigators.”

National alignment and strategic investment

ACT-CTU is part of a broader pan-Canadian effort to accelerate and strengthen investigator-led trials.

Across Canada, long-standing barriers — particularly around contracts and ethics approvals — have slowed multi-site research. Through ACT, national initiatives such as a Central Ethics Board and a Master Clinical Trial Agreement are helping streamline study start-up and reduce administrative delays.

By aligning with these reforms, The Institute is strengthening its ability to lead national and multi-site trials.

“Our partnerships — provincial, national and industry — are essential,” Dr. Pamidi said. “They allow us to scale, to innovate and to compete globally.”

Innovation in trial design

Advancing clinical trials is not simply about increasing volume. It is about evolving methodology.

Research Priority 4 emphasizes innovation in trial design, from adaptive and platform trials to biomarker-driven stratification and decentralized approaches.

Under the leadership of Philippe Boileau, PhD, the Novel Trial Methods Hub is strengthening methodological expertise across disciplines. Working with collaborators such as Shirin Golchi, PhD, and the , the Hub supports investigators in designing more rigorous, responsive and precision-driven studies.

Investigators at The Institute, including , and , are advancing adaptive and platform trial designs across disease areas.

“Precision health doesn’t end at discovery,” Philippe Boileau said. “It has to be embedded in how we design trials.”

Equity and representation

Innovation also means inclusion.

Ensuring that clinical trials reflect the communities they serve is essential to generating meaningful evidence.

Collaborations with leaders such as , a recognized expert in childhood disability and determinants of health and leader of Research Priority 5, are advancing efforts to improve generalizability in clinical trials. Data science contributions from , senior scientist at The Institute, head of its Strategic Research Priority for Digital Health and Data Science and leader of Research Priority 3, are helping define what representative recruitment should look like at scale.

“Equity isn’t an add-on,” Annette Majnemer said. “It’s fundamental.”

Through ACT-CTU, Dr. Louise Pilote has also developed practical tools to support the inclusion of populations historically underrepresented in research.

Together, these efforts aim to ensure that evidence generated at The Institute applies not just to a subset of patients — but to all patients.

From vision to impact

On February 17, 2026, The Institute hosted the Clinical Trial Symposium — From Vision to Impact at the Glen Site.

The full-day event brought together investigators, trainees, research staff, patient partners, industry stakeholders and policy leaders to examine institutional capacity, novel methods, equity and partnership development, reflecting the breadth of Research Priority 4.

For Dr. Pamidi, the symposium marked both a milestone and a springboard.

“It was an opportunity to bring the clinical trials community together, share ideas, spark new collaborations and identify where our strengths and resources lie,” said Amanda Lovato. “From here, we can move forward with unity and purpose toward our ambitious 2030 Vision for clinical trials at The Institute.”

“Successful clinical trials depend on multiple elements — regulatory support, methodological expertise, partnerships and infrastructure. The symposium highlighted that we have all of these in place at The Institute and are well positioned to meet our 2030 Vision,” said Dr. Rita Suri, a scientist in the .

The road to 2030

The 2030 Vision sets clear goals for strengthening clinical trial leadership at The Institute — from increasing investigator-led and early-phase studies to streamlining processes and expanding inclusive recruitment.

Success will not be measured by numbers alone, but by impact: faster translation of discovery into care, stronger national partnerships and trials that reflect the full diversity of the communities served.

Advancing clinical trials is central to how The Institute turns scientific excellence into measurable health impact.

“Ultimately,” Dr. Pamidi said, “we want to ensure that when a discovery happens here, it doesn’t sit on a shelf. It moves — efficiently, rigorously and equitably — into patient care.”

At the institutional level, that commitment is central to The Institute’s research strategy.

“Clinical trials are the engine that drives medical discovery into real-world impact,” said , Executive Director and Chief Scientific Officer and senior scientist at The Institute. “Through our 2030 Vision, we are strengthening the infrastructure, partnerships and scientific leadership needed to ensure that discoveries made here translate into better health for patients and communities.”

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