Staying compliant and efficient in the ever-evolving landscape of clinical trials is crucial, especially for Canadian sites and sponsors. In a recent Florence Healthcare webinar, we addressed important regulatory updates, privacy considerations, and strategies to streamline research efforts, particularly for those in Canada. With our special guest Dr. PJ Devereux, Director of the Division of Perioperative Care at McMaster University, we examined the recent regulatory changes, and supporting steps to take to ensure compliance for Canadian sites and sponsors.
Understanding Recent Canadian Regulatory Changes
Canada has been the talk of the industry lately for recent efforts to streamline their clinical trial regulations. These efforts have produced: New privacy legislation that requires heightened data protection for participants, as well as enhanced expectations around informed consent documentation and procedures.
There’s also been a concerted effort to promote greater alignment with global standards, particularly with U.S. and EU frameworks, to simplify multi-national trial coordination.
Regardless of where you’re based, it’s a good idea to review Health Canada’s updated guidance and ensure staff are trained in new privacy protocols, as Canada conducts approximately 900 clinical trials annually, as authorized by Health Canada. This represents about 4% of global clinical trials, making Canada fourth worldwide in the total number of clinical trial sites.
Data Privacy and Security in Canada
During the webinar, our panel stressed the importance of protecting participant data under both provincial and federal privacy laws. Sara Saunders, Sr. Manager of Regulatory Affairs at Florence Healthcare, outlined the importance of privacy compliance. In a world increasingly inundated with data it’s tempting to assume that data privacy applies more to social security numbers and government identifiers rather than the types of health data that clinical trials leverage.
However, Sara underscored how crucial it is – not only for regulatory adherence but also for maintaining participant trust. Trust and data go hand in hand, because the transparency required for data collection – even – and especially -in clinical trials, falls heavily on the participant.
Improving Participant Engagement and Retention
While retention has long been the domain of software companies and SaaS platforms, it’s also an increasingly critical concern in clinical trials. Dr. Devereux highlighted the rising importance of creating solutions that address participants’ concerns, improve communication, and ensure participants feel supported throughout the clinical trial journey and the necessary steps to focus on participant retention. Although it may seem like a nice-to-have, engagement efforts like these are essential for reducing dropout rates, improving study continuity, and ultimately enhancing the quality of trial outcomes.
Simple things like using digital communication tools to provide timely updates and reminders, and offering flexible visit options, including hybrid or remote visits, are a good first step in increasing participant engagement, which leads to better retention rates. Similarly, fostering a strong rapport with participants through personalized communication is also a good way to build engagement – and technology exists to streamline this process and make it easier for site staff.
Technology’s Growing Role in Research
The technological revolution is well and truly shaping the future of clinical trials, both in Canada and around the world. Globally, the use of eConsent has seen significant growth. In 2020, the number of clinical trials utilizing eConsent was 600% higher than in 2019, with an additional 17% increase in 2021. (GlobalData. (2021). E-consent patient tool adoption surges in clinical trials. Clinical Trials Arena)
eConsent has become the norm for efficient participant onboarding, and digital tools that streamline data collection while ensuring accuracy and compliance – as well as platforms that enhance collaboration between sponsors and sites for smoother project management are becoming increasingly popular as well. As these and many other new technologies continue to make the process of clinical trials easier for participants, it’s also important to acknowledge the necessity of ensuring that your platforms also streamline workflows for site staff, CRAs and other stakeholders.
Final Thoughts
As Canada continues to enhance its regulatory framework, both sponsors and sites must adapt proactively. Embracing updated privacy practices, leveraging the right technology and greater sponsor-site collaboration, and fostering participant engagement will be key to ensuring a successful year.
Are you a Canadian Site or Sponsor? Download our Guide Practical Considerations for eRegulatory Adoption in Canada