20 Months of Turbulence: Clinical Trials During COVID-19

20 Months of Turbulence: Clinical Trials During COVID-19

December 8, 2021 By

Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing demand for COVID-19 related products. However, many therapeutics, natural health products, medical devices, and medical regimens still require scientific substantiation to support successful regulatory submissions.

Health Canada provides review, oversight, and approval of clinical research pertaining to pharmaceuticals, medical devices, nutraceuticals, and natural health products conducted in Canada – holding these trials and their safety and quality considerations to an exceptional standard. Additionally, Health Canada has developed an expedited pathway for the review and approval of clinical research trials for drugs, medical devices, and natural health products used to treat, diagnose, or reduce symptom severity of COVID-19. These applications are reviewed according to ongoing and evolving priorities. As new therapeutics and diagnostics are authorized for use, priorities are shifted to areas that are more urgently required to satisfy public health needs.

Health Canada continues to review and approve Clinical Trial Applications (CTAs) for all products in accordance with its internally mandated service timelines. Some of these timelines are expedited to address urgent public health needs, while others are still subject to regular service standards. Sponsors from around the world have appreciated the continued or expedited review of their applications during COVID-19, with each application being reviewed with a risk-based approach with regards to trial feasibility and safety.

Throughout the pandemic, many countries experienced disruption of clinical trials. However, Canada’s regulations with respect to COVID-19 considered research an “essential service”. As a result, clinical research sites remained operational while incorporating all precautions mandated by local and global health authorities. This proved to be an advantage for Sponsors to conduct research in Canada when facing delays, disruptions, and other challenges elsewhere. With rigorous and well-recognized regulatory oversight, research in Canada proved to be an excellent option for global sponsors in order to maintain their internal timelines.

dicentra continues to apply a vigilant approach for ensuring local and federal regulations with respect to COVID-19 are adhered to despite ongoing changes to these regulations. Our experience navigating COVID-19 regulations has assured Sponsors of our ability to conduct their trials without disruption by adapting recruitment and clinical conduct strategies.

About us:
dicentra is a full-service Contract Research Organization (CRO) and professional regulatory consulting firm that specializes in addressing matters related to safety, quality, and compliance for all product categories in the life sciences and food industries.

Our in-house research clinic is located in the heart of downtown Toronto, one of the world’s most multicultural cities. With over 6.5 million people located in this area, we are able to efficiently recruit study subjects for clinical trials, allowing our study Sponsors to obtain results and achieve their objectives sooner.