National Clinical Trials Governance Framework

Following the pilot, it is anticipated that clinical trial services will be assessed using a maturity scale to the actions identified in the National Clinical Trials Governance Framework. If you work in clinical trials, this video provides you with useful information on the implementation of the Governance Framework and will help you understand how to prepare for accreditation.

• What is the National Clinical Trials Governance Framework?

MSH clinical trials – open for recruitment

• Those interested in participating in Translational Research Institute (TRI) clinical trials and research projects are able to access the TRI Clinical Trials and Research Studies page and register their interest.
• Alternatively, patients are encouraged to speak with their treating practitioner in relation to clinical trials which may be available.

Why conduct a clinical trial in MSH?

• MSH has many advantages as a place to conduct clinical trials. This is because MSH and the TRI is home to some of the world's best researchers and health professionals and boasts a world-class research infrastructure, a stable socio-political environment, and high standards that ensure confidence in the scientific conclusions reached by clinical trials conducted in Australia.
• MSH has a simple and efficient regulatory regime. These are all factors that have contributed to the strong growth of investment in clinical trials in MSH by global biopharmaceutical and medical technology companies over the past three decades.
• International standards of conduct for clinical trials, developed by the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO), provide a benchmark of clinical research quality that can be relied upon throughout the world. Under the Therapeutic Goods Act 1989 and associated regulations, ICH or ISO Good Clinical Practice (GCP) standards are mandatory for all Australian clinical trials involving unapproved medicines or medical devices. Many Australian researchers have international experience and are familiar with GCP and other guidelines.
• Australia adheres to the highest level of GCP standards, meaning that Australian clinical data and results are accepted by international regulatory agencies, including the United States Food and Drug Administration and European Medicines Agency.
• The Australian Therapeutic Goods Administration (TGA) has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) in principle, with some elements modified according to local regulatory requirements (see Note for guidance on good clinical practice).

International and Australian research sponsors

• International and Australian research sponsors can develop and support the highest quality clinical trials and benefit from the advantages of the Australian clinical trials environment, including top-rated facilities and researchers, efficient review and regulatory frameworks and financial incentives.
• The resources on this site are designed to assist with this process by providing information and guidance.
• Sponsors are also encouraged to review the information contained in the Clinical Trials Guideline (GL2020/TBA).

Efficient ethics and regulatory framework

• Australia has a fast and pragmatic regulatory pathway for clinical trials. Under the Clinical Trials Notification (CTN) scheme administered by the TGA, research proposals are submitted directly to certified Human Research Ethics Committees (HRECs) which assume the primary review responsibility for ethical and scientific review.
• Metro South Health operates an extremely efficient HREC.
• Metro South Health has adopted the streamlined ethical clearance process for multi-centre research that helps to reduce unnecessary duplication of review of research.

Diverse participant recruitment pool and healthcare environment

• MSH has an informed and willing population of potential trial participants, resulting in a higher level of research participation than would be expected from a population of our size. Australia is a multi-cultural country with a diverse population that is capable of meeting recruitment needs.
• MSH clinical practices and some aspects of our health care system are similar to the United States, the United Kingdom and most of Europe.

Investment incentives

The Australian Government’s generous Research & Development (R&D) Tax Incentive encourages more industry investment in R&D.

The Incentive provides businesses investing in eligible R&D with generous tax offsets:

• a 45 per cent refundable R&D tax offset (equivalent to 45c per $1 of eligible R&D) for companies with aggregated annual turnover of less than A$20 million
• a 40 per cent non-refundable R&D tax offset (equivalent to 40c per $1 of eligible R&D) for all other eligible companies.

Other benefits under the new R&D Tax Incentive include:

• clinical trials can be eligible R&D activities under the program and are considered for eligibility under the same rules as any other activity
• the incentive provides for increased access by international companies and there is no requirement to hold the IP in Australia
• certainty and stability of the rate of support to companies as the rates are no longer linked to the company tax rate
• Increased level of expenditure that can be claimed on R&D activities undertaken overseas in support of Australian R&D projects, under certain conditions.

Above all, the new system provides a globally competitive tax incentive for conducting R&D activities in Australia. 

Seasonal differences

• The seasonal differences between the Northern and Southern hemispheres allows trials dependent on seasonal factors (eg flu vaccine, allergy or respiratory ailments trials) to be conducted or continued in Australia, extending the appropriate period for patient/participant recruitment.
• Queensland also offers increase instances of skin cancer a melanoma due to our seasons and lifestyles.

Government commitment to clinical trials

• The Australian Government is committed to improving the clinical trials environment in Australia. 
• More details on the initiatives that will improve the clinical trials environment, along with their progress are available on the Australian Government Clinical Trials webpage.

Service providers

• MSH can provide additional clinical trial and research support via our service departments including Pharmacy, Radiology, Pathology and the Clinical Research Facility.
• Standard fees are attached to the Research Fees Procedure which are subject to periodic review.
• For detailed requirements, please consult directly with the service provider.