In Australia, health and human research is delivered by teams of clinical investigators, clinical and non-clinical staff working in partnership with trial sponsors, the regulator, research participants, consumers, patients their families and carers. Health and human research is largely delivered in public and private health service organisations and trial sites ranging from sole proprietorships to large statutory corporations and public companies.
Patients, consumers and the community trust clinicians and health service organisations to undertake high-quality research in a safe environment and believe Australians should have equitable access to relevant clinical trials as part of routine care or as an additional treatment option. Australia generally performs well in international comparisons in the quality of research conduct and Australia’s health and human researchers are highly regarded as skilled clinical researchers and clinicians who are committed to meeting the healthcare needs of their patients. An active clinical trials and health and human research environment supports the retention of clinicians and medical researchers in our health care system through the provision of technical skills and global recognition of their contribution to international research.
Since 2017, the Commission, on behalf of the Australian Government Department of Health (the Department) and all jurisdictions, has worked to progress key elements of the Revitalised Clinical Trials Agenda via the Encouraging More Clinical Trials in Australia budget measure. This has been the key overarching national initiative driving reform and efficiency in the clinical trials and health and human research sector including in the development of the draft National Clinical Trials Governance Framework which was endorsed by all Health Ministers in 2019. The outcome will be the integration of clinical trials into health service corporate and clinical governance systems and nationally consistent accreditation of clinical trial services under the National Safety and Quality Health Service Standards.
The Commission's Framework for Australian Clinical Quality Registries provides the national foundational principles for clinical quality data collections and the Commission leads and partners with other government agencies across a range of projects to support the meaningful use of data to improve safety and quality in health care. In 2019, the Commission launched the Australian Register of Clinical Registries.
Currently, the Commission is conducting national consultations to scope the requirements for a national health and human research platform – The National One Stop Shop and National Clinical Trials Front Door. This proposal for an interconnected and sustainable national platform for all health and human research, represents transformative change for the sector. At a minimum, the proposed national platform has jurisdictional and industry support to reduce duplication, expedite trial commencement and enable the first real-time national picture of health and human research activity.