In support of the clinical trials sector during the COVID-19 pandemic, a position statement has been developed by the Research and Development TaskForce (RDTF), sponsored by AusBiotech, Medicines Australia, and the Medical Technology Association of Australia, together with respective memberships.
This position statement details specific guidance on how and why clinical trial sites should remain open during the COVID-19 healthy emergency. As the COVID-19 pandemic unfolds in Australia, additional strategies will need to be implemented to ensure that the safety, well-being and ongoing conduct of clinical trials are maintained, with as little interruption and inconvenience to the participant as possible.
A flexible and supportive clinical trials environment should ensure that Australian patients are best placed to receive early access to experimental vaccines and treatments for COVID-19, and other innovative treatments, that they would otherwise not have access to.
The RDTF has formed a COVID-19 Working Group to support the clinical trials sector as the effects of the COVID -19 pandemic are felt around the nation. It is acknowledged that a strong collaborative sector-wide effort will be required, as there are many stakeholders involved in the delivery of clinical trials. The Working Group will look at all aspects of clinical trial delivery with the intent of ensuring that trial participants and trial sites are supported and where possible, that patients continue to receive treatment and all safety activities are completed.
Clinical trials remain critical in the path to bringing innovative drugs, vaccines and therapies to consumers and patients in Australia in a safe and regulated manner. Australia has well-developed and highly-regarded early phase clinical trial facilities, and other trial centres and expertise to conduct clinical trials for COVID-19 treatment and prevention. These facilities are well prepared and immediately ready to assist in the development of these treatments, should they be required.
The safety of patients and clinical trial staff employees is at the forefront of the RDTF’s minds, and the unrelenting efforts of scientists, physicians, nurses, and allied healthcare workers during the course of this pandemic is inspiring.
Australia is not only a world leader in life sciences research and development, but resilient in the face of any health and economic crisis; industry is strongly supportive of the clinical trial sector through these unprecedented times.
Download the position statement here.
Elizabeth de Somer Lorraine Chiroiu Ian Burgess
CEO, Medicines Australia CEO, AusBiotech CEO, MTAA