Pediatric Trials Deserve Better: Cutting Red Tape to Protect Canada’s Children

georgschmoelzer
2 days ago
2 min read

Every day across Canada, children receive medicines that were never properly tested for them.From antibiotics to pain relievers and steroids, many of the drugs routinely used in pediatric care lack high-quality evidence specific to infants and children. Doctors are often forced to rely on adult data, best guesses, or decades-old studies when making critical treatment decisions.

Why? Because Canada’s current clinical trial regulations make it unnecessarily difficult—and costly—for researchers to study medicines that are already part of standard care for children.

The Problem

Health Canada’s existing framework treats all drug trials as though they pose the same level of risk. This means that even low-risk pediatric trials—those studying drugs already prescribed daily in hospitals and clinics—face the same heavy regulatory and administrative burden as trials testing new or experimental drugs.The result?

Fewer pediatric trials.
Longer approval timelines.
Higher costs.
Missed opportunities to generate the evidence we need to give children the safest, most effective care possible.

While other countries have modernized their regulations to focus oversight on high-risk or experimental studies, Canada has fallen behind—discouraging homegrown innovation and driving research talent elsewhere.

The Solution

A new white paper, “Pediatric Routinely Administered Clinical Therapeutics in Everyday Practice Trials: Regulatory Reform to Advance Evidence-Based Pediatric Care,” calls for Health Canada to establish a full exemption pathway for low-risk pediatric clinical trials.

This reform would:

✅ Exempt studies involving drugs already used safely in children from unnecessary regulatory processes.

✅ Reduce financial and administrative barriers for Canadian researchers.

✅ Accelerate the pace of pediatric evidence generation.

✅ Maintain strict ethical and safety standards already upheld by pediatric research centres across the country.

By adopting a risk-based regulatory approach, Canada can align with global best practices—ensuring that oversight is proportional to the true risk of a trial, not its paperwork.

Why It Matters

Every child in Canada deserves access to the safest, most effective treatments based on solid evidence—not assumptions.Reforming outdated regulations will:

Speed up access to evidence-based care.
Improve outcomes for vulnerable pediatric patients.
Help Canada reclaim its place as a global leader in child health research.

The Call to Action

Canada’s pediatric community—researchers, parents, clinicians, and policymakers—must unite to urge Health Canada and the federal government to modernize clinical trial regulations.It’s time to make sure our rules support, rather than obstruct, the generation of evidence that keeps our children healthy.

Because when we make research easier, we make care better.

Read the paper here: