Driving randomized trials for global impact

Image of Dr. Amit Garg

A new initiative supports researchers in conducting randomized trials that directly influence health care and policy

Large-scale, randomized trials are considered the ‘gold standard’ of evidence in modern health care – but the journey from trial design to completion is extremely complex, time consuming and expensive.

From protocols to data collection to the regulatory landscape in Canada, the process is onerous and often inaccessible for individual researchers.

Recognizing these barriers, Schulich Medicine & Dentistry is spearheading an initiative to drive more trials at the School and elevate our capacity to develop and lead trials that test solutions most likely to benefit health.

The purpose of this new initiative is to bring the right people and resources together to help researchers conduct randomized trials in a more efficient and effective way, with bigger impact.

Researchers will receive support with developing protocols and methodology, streamlining consent approaches, leveraging existing data sources and data management. The trials will be conducted with patients, health care administrators, scientists, health professionals and industry as full partners.

We are embracing innovations in trial execution, and we think this will be a game changer. We’re confident that in a decade, this will prove to be a highly successful enabler of high-quality research and impact in our community.

Our team has launched one arm of the trial initiative called S5 – supporting researchers to conduct streamlined trials, testing solutions which are simple, scalable and sustainable. Streamlined, large, pragmatic, randomized trials typically test a low-risk solution with an efficient approach to patient consent. The promising solution is delivered in routine care without research coordinators, and existing data sources, such as large health care administrative databases, are leveraged for the trial needs to minimize the need for additional data collection.

We’ve been working closely with advisors from partner faculties at Western, as well as ICES Western, AMOSO, Lawson Health Research Institute and London’s hospitals. The partners are working together to ensure a positive, streamlined experience, which will enable researchers to go further and faster in what they want to achieve.

In addition to the S5 platform, the clinical trials initiative will also support researchers with first-to-human trials, and we will be working with stakeholders to build a plan for this in 2022. We’re also working on funding mechanisms to support proposal development and new projects.

The long-term vision for the randomized trials initiative is to establish a strong international reputation at the School and University, producing research with global impact.

What we would like to realize in the next decade is that we’ve enabled faculty to efficiently conduct and execute high-quality trials, and the trial results are well-received by experts and top health-care journals.

Ultimately, our goal is for trial-proven, beneficial treatments and solutions to be used broadly to improve human health.

Dr. Amit Garg
Associate Dean, Clinical Research Professor, Departments of Medicine and Epidemiology and Biostatistics