07 April 2020
Pictured: Clinical trial in progress. Image courtesy of Linear Clinical Research.
As the COVID-19 situation is developing rapidly, the sector is working together to ensure continuity of current clinical trial research for the thousands of patients currently enrolled in trials around Australia.
The Research & Development Taskforce (RDTF), represented by Medicines Australia, AusBiotech and the Medical Technology Association of Australia who support the development of innovative new medicines and medical devices, released a joint position statement ‘Supporting Clinical Trials During the COVID-19 Pandemic’.
The Taskforce has formed a COVID-19 Working Group to identify practical solutions to support clinical trial sites as all parties work together to mitigate the effects on clinical trial patients until the COVID-19 situation eases.
Following, the Federal Department of Health issued important information about the ongoing management of current clinical trials during these challenging times.
Included was guidance - COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors – which aims to:
- Assist those overseeing, conducting and reviewing clinical trial research to maximise the safety of research participants and to minimise risks to participants and the community, to researchers and other institutional staff and to trial integrity, and
- To address prioritisation of clinical trial research.
It reflects the shared views of the all state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG).
The TGA provided an update on clinical trial processes including the Clinical Trial Notification (CTN) scheme for clinical trials relating to treatment or prevention of COVID-19 and clinical trials already notified under the CTN scheme. The TGA is handling enquiries relating to COVID-19 as a priority. For any questions regarding the clinical trial schemes please contact the clinical trials team at +61 2 6289 4614 or email email@example.com
The NSW Office for Health and Medical Research has drafted the NSW Health guidance for sponsors, researchers, HRECs and RGOs for conducting clinical trials affected by the COVID-19 situation. The guidance, modelled on similar advice from the HRA in the UK, is designed to assist operational requirements in NSW and will be continually updated as the situation evolves. The Victorian health department has also provided updated guidance.
For further information about the COVID-19 impact on clinical trials, MTPConnect is sponsoring the ARCS Webinar series, a free 10-week webinar series focused on considerations and strategies for running trials during the pandemic. Find out more here.