Some impacts of COVID-19 on Australian Clinical Trials

by | Mar 4, 2021

The requirements of COVID-19 containment and isolation have had a profound effect on all aspects of community life in 2020 and beyond. What has the impact been on clinical trials in Australia?

Feedback from the market indicates that clinical trials activities were up and down over the majority of 2020.

Some observations are that during the first wave of restrictions and for a period thereafter, new patient recruitment was significantly reduced by around 60%; many studies were suspended; new clinical trials were not being initiated as sponsors were uncertain about what would happen next; patients were not attending their scheduled visits and there were many COVID-19 related protocol deviations. Hospitals cited clinical trial-related revenue as significantly reduced.

During this time, hospitals and clinics did not permit or severely restricted access to clinical research staff and company staff in general, meaning that monitoring could not progress as planned. There has been some hesitation about considering new clinical trial work in Australia due to the inability to travel and to meet and greet with Investigators, service providers, review clinical trial facilities and initiate studies face to face.

Pandemic considerations have seen Australia compared with other countries offering exemptions to travel and entry for critical personnel and activities such as clinical trials. Some have pivoted their clinical trial investment and activities elsewhere for this reason. Nevertheless, many sponsors are still bringing work to Australia. With serious diseases like cancer, recruitment of patients has continued almost unabated. Less so for diseases of the elderly and / or milder diseases.

The US FDA provided quite good guidelines regarding trials during the pandemic to ensure quality met with their standards.

Australia is being looked at with fresh eyes as a ‘safer’ country in which to conduct clinical trials, due to its lower incidence of COVID-19 infections. This influx of work has created a significant skill shortage with CRAs, project managers, statisticians and data managers being extremely hard to recruit.

Through the efforts of all Commonwealth and State Governments and communities, Australia is lifting itself out of the pandemic. The unparalleled speed of work in 2020 internationally has taken us from deciding on a target in January / February to having two vaccines ready to seek approval or approved in some jurisdictions in less than a year and 40+ vaccines in clinical development.

Funding for biotechnology worldwide has remained strong during the pandemic and currently shows no signs of slowing down. This sector typically does not follow general economic up or downturns.

The daily discussion in the general media about clinical trials has brought the sector to the top of mind for most people on a global basis and enhanced the reputation of therapeutics innovators in the minds of the public. The recent support from the Australian government for the R&D Tax Incentive in the Commonwealth budget has contributed to greater confidence in the sector.

Venture Technology Group (VTG), is a life science consultancy. We invite you to consider development of your life science assets in Australia with Venture Technology Group and Collaborative Partners.