To mark International Clinical Trials Day (May 20), we spoke with Dr. Amit Garg, associate dean of Clinical Research at Schulich Medicine & Dentistry and a world-renowned clinician-scientist with Lawson Health Research Institute and the Institute for Clinical Evaluative Sciences.

In our conversation with Garg, he highlighted broader clinical research efforts towards training and supporting world-class trial leaders in London, Ont. and across Canada.

He also emphasized the School’s commitment to building a strong culture of evidence-based research by supporting clinical trials – through funding and by empowering the next generation of clinical trialists.

How can clinical trials strengthen Canada’s health-care system – now and in the future?

When researchers discover a possible solution or intervention for a health-care problem, they often need solid evidence to support it. That’s where clinical trials – especially large randomized clinical trials – come in, helping us build confidence that the interventions we’ve discovered are truly effective for the outcomes that matter most to people and society. This is how we test the effectiveness of vaccines, for example.

There are different types of trials. Large, well-conducted, multi-centre randomized controlled trials, in particular, yield the highest quality of evidence when evaluating an intervention’s effects. They often inform clinical guidelines and public health policies.

Large, well-conducted, randomized trials give us our best estimates of treatment effects, helping us make better decisions about policy, programs and health care.

You specialize in pragmatic clinical trials. How do these differ from traditional ones?

Traditional trials are often conducted in ideal conditions, where situations are highly controlled using strict experimental methods. However, in pragmatic clinical trials, the intervention is delivered the same way it would be in routine care.

In some settings, pragmatic trials are more effective than traditional approaches because they allow us to test interventions in better, faster and cheaper ways. They stand out from other trial designs due to their practical potential for real-world uptake, as well as their cost and time efficiency.

Can you think of situations where a pragmatic clinical trial isn’t the right approach?

A pragmatic trial would not be relevant, for example, when testing a vaccine for the first time in human beings. But suppose two vaccines have already been approved and are available in pharmacies—if there are questions about the effectiveness or side effects of one or both, a pragmatic trial would be a very good way to generate definitive answers.

Questions related to first-in-human work, drugs with high toxicity or potential harm, or treatments we don’t yet have much experience with should not be addressed through pragmatic clinical trials. In my opinion, these questions are better answered through more exploratory trials, with strong oversight and detailed safety monitoring during the trials.

Pragmatic clinical trials work best when fully embedded into routine health care.

What are the biggest misconceptions about clinical trials?

The public sometimes thinks that clinical trials are risky. While it’s true that clinical trials carry some risks, so does usual care. In fact, the greater risk may come from not having solid evidence or being treated in a system where we lack information about the effectiveness of routine care.

In many cases, procedures in clinical trials are subject to greater oversight than they would receive in traditional health-care settings.

What is the current state of clinical trials in Canada? Are we conducting enough of them?

We need many more clinical trials taking place in Canada. This is especially evident when we consider that most decisions we make about treatments in medicine today are not supported by high-quality evidence.

Do you think clinicians and researchers in Canada have enough resources and support to become clinical trialists, or are there gaps?

Certainly, there are some gaps, which is why the Canadian Institutes of Health Research (CIHR) invested $39 million for the development of the Accelerating Clinical Trials (ACT) Canada Consortium. CIHR also funded seven clinical trials training platforms, including the Health Data Research Network Canada (HDRN) Pragmatic Trials Training Program, which is one of these platforms.

Western University has also been making significant investments in clinical trials. At Schulich Medicine & Dentistry, we are tirelessly working on training a new generation of world-class trial leaders that can move forward with our local health-care system in London, as well as advance the health-care system in Canada more broadly.

Our goal is to empower more faculty to lead high-quality, high-impact randomized trials. In addition to coordinating the pragmatic trials training program, Schulich Medicine & Dentistry also coordinates the Pragmatic Trials Services platform, a non-profit platform that aims to assist teams or investigators in designing, executing, and translating pragmatic trials.

What’s one thing you want researchers to know about pragmatic clinical trials?

When done well, pragmatic trials allow us to fill evidence gaps in a faster, cheaper and more effective way than other methods.

If you can demonstrate that an intervention works in a pragmatic trial, where it is delivered in the same way it would be outside the trial, then the uptake and implementation will be much easier. This is because the process has already been worked out, and you can expect that the effects observed outside the trial will closely match those seen within it, since the intervention was delivered in the same manner during the trial.