The Advantages Of Conducting Early Phase Clinical Research In Canada

Timely completion of essential studies plays a vital role in drug development, ensuring the availability of crucial treatments for patients in a safe and cost-efficient manner. When it comes to early-phase clinical trials, particularly first-in-human (FIH) trials, the choice of trial location can have a measurable impact.

Depending on the specifics of a program, the advantages of a Canadian strategy can vary. To begin a clinical trial in Canada, researchers must submit a study-specific Clinical Trial Application (CTA) to Health Canada (HC) for approval. Simultaneously, the study materials are also submitted to an Ethics Review Board. The results of the studies conducted under a Canadian CTA can be utilized to support an Investigational New Drug (IND) application in the United States or a request for marketing authorization in the European Union (EU), the United Kingdom (UK), as well as other regulatory regions including Asia and Brazil.

These studies are then conducted following International Conference on Harmonization (ICH) guidelines, which adhere to high-quality standards and regulatory ethics, making them valuable for supporting global drug applications by agencies like the U.S. FDA and European Medicines Agency (EMA).

Planning a well-designed clinical program in Canada not only ensures a cost-efficient, safe, and timely execution that meets regulatory requirements for market authorization in various jurisdictions, but it has been noted that Canadian early-phase CROs often utilize these studies for submissions outside of Canada.

Access the e-book below to learn more about the significant advantages of conducting early-phase clinical research on novel compounds in Canada compared to other locations.