Clinical trials: lessons from the pandemic and time for change

24 October 2022

The editorial was first published by the Canadian Science Policy Centre. It shines a light on what the pandemic taught us about the importance of clinical trials, an evolving clinical trials landscape in Canada and abroad, and the way forward.

The COVID-19 pandemic has taught us many lessons about science and technology. It has underlined the importance of quicker and smarter surveillance and responses to public health emergencies. The pandemic showed us how telehealth can be an accessible and effective health care option, and that preventative measures such as masks and physical distancing are useful to keep ourselves and others healthy. It has also demonstrated the value of clinical trials for developing safe and effective vaccines and treatments.

Clinical trials are essential scientific studies that evaluate the safety, effectiveness, and outcomes of health interventions. In doing so, they help move health research from the bench to the bedside.

Data also shows that hospitals with clinical research activity are associated with reduced mortality and improved overall care quality.

Clinical trials as a health care option provide patients with access to promising new treatments that they would otherwise not have. This is of increased importance when addressing rare or emerging diseases. In addition to producing quality evidence for regulatory and health-care decision-making, clinical trials also contribute to job creation. For example, in 2019, The BMJ reported that clinical research contributed an estimated £2.7 billion to the UK economy and supported more than 47,000 jobs.

However, fundamental challenges exist in the conduct of clinical trials in Canada and internationally despite their foundational importance to optimal health care.

Canada has a rich history of supporting breakthroughs in response to health emergencies and clinical trials have played a key role in enabling that. In the 1950s, researchers at Connaught Laboratories at the University of Toronto developed what was called “the Toronto Method,” which made mass production of the first successful polio vaccine possible. American researcher Dr. Jonas Salk who created the vaccine called Canada’s effort “herculean” in the largest medical experiment ever undertaken. In 2003, BC researchers were the first in the world to decode the SARS virus, which provided the key evidence needed to develop vaccine candidates. Canada again contributed significantly to the development of the COVID-19 messenger RNA (mRNA) vaccines through the work of University of British Columbia’s Dr. Pieter Cullis and his colleagues.

Uncertainty underpins an evolving clinical trials landscape

The COVID-19 vaccines were developed in a time of tremendous uncertainty and pressure. What would typically take 10 years was achieved in less than one.

Resilience in the face of an extraordinary event enabled this acceleration. It included increased international collaboration and focused determination by the scientific and medical communities, government, and manufacturers; quick data sharing and learning across different time zones and language barriers; and technology and preparedness protocols developed and tested long before the pandemic. While these factors were delivered, the pandemic also illuminated the critical need to continue to build strong infrastructures for clinical trials so that we are better prepared to respond to future public health crises.

A paper published in The Lancet and authored by Canadian and international researchers showed that the pandemic has not only re-emphasized the importance of well-designed randomized clinical trials but also highlighted the need for large-scale clinical trials structured according to a master protocol in a coordinated and collaborative manner.

In support of co-ordinated efforts to conduct high-quality clinical trials and to increase the relevance of results applicable to our local population, it is important that provinces in Canada are better enabled to participate in national and international clinical trials.

The clinical trials landscape is evolving nationally and internationally in response to advances in technology, product development, methodologies, and the global challenge of the pandemic. Many developments are underway to further build resiliency in the clinical trials environment to inform decision-making more efficiently during and after public health threats.

Health Canada is proposing to modernize the regulatory framework for clinical trials. On June 22, the Honourable Jean-Yves Duclos, Minister of Health, officially launched the Clinical Trials Fund (of $250 million over three years), which is an integral component of Canada’s Biomanufacturing and Life Sciences Strategy. Quebec has a new provincial government mandate to bring together clinical research stakeholders under CATALIS Quebec to accelerate clinical research, which will speed up the generation of new health knowledge. In the UK, the government and other stakeholders are rebuilding their clinical research environment.

Time for change

In British Columbia, several initiatives are progressing to support and streamline the creation and use of evidence, demonstrating the commitment of the government, the research community, and the health care system to collaborate on “recovering better.” For example, Clinical Trials BC (part of Michael Smith Health Research BC) recently engaged 170 stakeholders Canada-wide to gain a more robust understanding of BC’s strengths, challenges and opportunities in the areas of clinical trials capacity, expertise, review and approval processes, and culture. Stakeholders came from health, research, policy, funding, and industry, including patients and previous clinical trial participants.

Bringing this diverse group together was possible because of Health Research BC’s established and extensive network of stakeholder relationships, learnings from previous consultations in BC, and guidance from the Clinical Trials BC Advisory Council.

Engaging stakeholders is a key component of Clinical Trials BC’s ongoing work to strengthen clinical trials capacity across BC, build and support clinical research infrastructure, and develop the talent that BC needs for the future.

Stakeholder engagement so far has made one thing clear — the clinical trials community is ready for change. To advance BC’s development as a world-class destination for clinical trials, we must build on BC’s comparative advantages and address persistent challenges to strengthen evidence-informed care, improve population health, and support economic growth.

We look forward to sharing engagement findings in the coming months, which could inform stakeholder engagement and clinical trials strategies across Canada. These are crucial times as we continue to build on lessons learned and work together to ensure Canada is well-positioned to deliver new life-saving health interventions from discovery to distribution in a variety of health areas.