AusBiotech to engage in clinical trials consultation

Biotech News: AusBiotech welcomed the first step towards a national front door for clinical trials, as the Australian Commission on Safety and Quality in Health Care announces scoping is underway on a national one-stop-shop and consequently, a ‘National Clinical Trials Front Door’.

According to Research Australia “Our low COVID-19 infection rates, world-class research community and strong health system should be a beacon, positioning Australia as the preferred global destination for clinical trials.”

AusBiotech has been supportive of the concept of a national front door, since it was mooted more than two years ago, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff. Health Minister Greg Hunt has previously acknowledged it as a “golden” opportunity for Australian clinical trials.

AusBiotech CEO, Lorraine Chiroiu, said “We’re supportive of the compelling opportunity of the one-stop-shop and a national front door for clinical trials. Australia offers a globally-competitive environment and by reducing the administration and supporting every stage of research – from application to approval and reporting – it will support us to cut the red tape, and roll out the red carpet, as Australian clinical trials remain open for business.”

The proposed national online portal for all health and medical research seeks to make it easier for researchers, industry and sponsors to find, conduct, participate and invest in research in Australia.

The consultation commences in July 2021 and aims to develop a national, interconnected, rapid and streamlined approvals platform that will:

• include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification and approval systems;
• incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration;
•  include an embedded and automated next-generation national clinical trials registry;
• provide sophisticated monitoring and reporting functionality for different users.

Options for improving patient recruitment through a related National Clinical Trials Front Door, will also be considered.

AusBiotech, together with its Clinical Trials Advisory Group, will be actively engaged in this consultation.