Why you should consider clinical studies in Australia 

Conducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages.

1. Advantages and disadvantages of clinical studies in Australia

1.1 Advantages of clinical studies in Australia

Advantage 1: Suitable population

Australia has a multicultural population. This diversity makes it possible to conduct studies on different ethnic groups. The population is generally very willing to participate in research studies.

Due to the relatively constant climatic conditions throughout the year, seasonal diseases such as infectious diseases have little impact on the results of clinical studies in Australia.

Advantage 2: Helpful research infrastructure and high quality standards

Australia’s infrastructure offers much that sponsors of clinical studies could wish for:

• The healthcare system has highly qualified clinical staff.
• State-of-the-art equipment is available in clinical research facilities.
• High-quality data is available. The Australian Department of Health AIHW provides statistics on risk factors, diseases, and deaths.
• Research facilities meet high-quality standards for clinical studies.
• Clinical practices are comparable to those in the USA, Canada, and Europe. This facilitates the transferability of research results.

Overall, Australia enjoys a good reputation for its scientific and medical research.

Advantage 3: Reliable regulatory framework

Sponsors benefit from regulatory safety:

• There are transparent guidelines for medical devices.
• The requirements for clinical studies comply with international standards.
• GCP standards are also binding for non-approved medicines or devices.
• International regulatory authorities accept Australian data and results.

Advantage 4: Financial support

Manufacturers benefit from the Australian Research and Development Tax Incentives (R&DTI). This Australian government tax incentive for research and development leads to partial cost refunds for funding applications. Qualifying companies may be eligible for a tax credit that reduces their tax burden. There are two key components of the credit:

• A 43.5% refundable tax credit for small and medium-sized enterprises (SMEs) with an aggregate annual turnover of less than AUD 20 million. If the business makes a loss, it can receive the credit as a refund.
• A non-refundable tax credit of 38.5% for all other businesses. If these businesses make losses, they can carry the credit forward to future tax years.

This incentive requires, in some cases, working with registered research service providers and leads to audits by the Australian Tax Office (ATO) to ensure that the activities claimed are legitimate.

1.2 Disadvantages of clinical studies in Australia

Disadvantage 1: Size and geographical distribution of test subjects

Compared to the USA and Europe, Australia’s “patient pools” are smaller, making it more difficult to recruit test subjects, especially for niche products. Australia has 26 million inhabitants (for comparison: North Rhine-Westphalia in Germany has around 18 million inhabitants). These inhabitants are geographically dispersed, leading to logistical problems, especially for test subjects who have to travel long distances.

Disadvantage 2: Obligation to have an Australian sponsor

In addition, companies that are not based in Australia require an Australian sponsor. This sponsor is responsible for registering medical devices (ARTG registration) and post-marketing activities such as incident reporting and recalls. The Australian sponsor’s name and contact information must appear on the device.

2. Regulatory framework for clinical studies in Australia

2.1 Applications

The Therapeutic Goods Administration (TGA) is Australia’s national health authority responsible for monitoring and approving medicines, medical devices, and blood products.

Researchers and sponsors must register their studies with the TGA and receive approval. For this registration, sponsors must submit an application for clinical investigation (CIN) or clinical investigation authorization (CIE).

Once the TGA approves the research application, the sponsor forwards it to the Human Research Ethics Committee (HREC) for ethical approval. This ensures that the study meets ethical standards. The National Statement on Ethical Conduct in Human Research has established guidelines and principles for research with human participants in Australia.

For example, the TGA examines the application to determine whether

• the safety, performance, and quality of the medical device are guaranteed,
• the planned study complies with the requirements of the Australian Regulatory Guidelines for Medical Devices (ARGMD).

2.2 Specific conditions for CE-marked devices

The TGA offers a simplified process for CE-marked devices.

• CE marking alone is not sufficient for conducting clinical investigations (PMCF studies) in Australia. A separate application must be made to the TGA.
• However, the TGA will accept parts of the technical documentation and data used for CE marking to reduce the audit burden. In particular, the summary of clinical data prepared for CE marking can serve as the basis for the application for clinical investigation in Australia.
• For class III high-risk medical devices and active implantable devices, the TGA conducts a level 2 audit and reviews the design dossier, even if CE marking has been obtained.

In summary, although CE marking facilitates the application process for clinical investigations with the TGA, it does not completely replace it. The TGA reserves the right to request additional documentation and to conduct its own audits, particularly for high-risk products.

In addition, the TGA recognizes the marketing authorizations of comparable regulatory authorities, including the European CE certificate of conformity. Most foreign companies seeking market access in Australia already have CE marking or FDA release.

However, (IVD) medical devices must still register with the TGA and apply for an ARTG number.

3. Procedure for clinical studies in Australia

When applying for clinical studies for medical devices in Australia, the following steps must typically be taken:

Step 1: Define study design and determine study centers

The first step is planning the study and determining the clinical study methodology.

Step 2: Submit TGA application

The sponsor first submits a clinical study application to the TGA (Clinical Trial Notification, CTN). This application contains the necessary documents for inspecting the medical device’s safety and performance.

Step 3: Obtain ethics approval

After assessment by the TGA, the sponsor must submit the documents and the outcome of the TGA inspection to the responsible HREC and submit a separate application for ethics review. The HREC then reviews the scientific validity of the study design, the benefit-risk-determination, and the ethical justifiability of the procedure and approves the study protocol if necessary.

Step 4: Obtain approval from the approving authority

In addition, the approving authority of the institution where the study is to be conducted must give final approval, taking into account the HREC recommendation.

Step 5: Register the study with the Australian Clinical Trials Registry (ACTR)

In this step, manufacturers must register the clinical study in the ACTR. This is intended to make the study transparent and promote the publication of results.

Step 6: Recruit participants and conduct clinical studies

Now, the actual clinical study begins. The study protocol is implemented, data is collected, and participants are recruited. The study is monitored on an ongoing basis, and it is ensured that all regulatory requirements are met.

Step 7: Analyze and report data

The collected data are analyzed in parallel and at the end of the study. The sponsor ensures that the clinical study report is prepared and that all necessary documents and reports are submitted to the competent authorities in accordance with the applicable regulations.

Step 8: Follow-up the study

Even after the study is completed, the manufacturer must monitor the medical device’s safety and effectiveness and, if necessary, submit safety reports and other relevant information to the authorities if additional information arises from the follow-up.

4. Duration and costs

The average application time for clinical studies of medical devices in Australia is around 6 to 12 months.

Application costs vary depending on the complexity (e.g., multicenter, complex study design, number of endpoints, number of cases, size of study site, etc.) and scope of the study, as well as the number of documents required and other factors. Typical cost items are listed below.

4.1 Application fees to the TGA (Therapeutic Goods Administration)

The application fees depend on the risk class:

class	fees (approx.)
class I	1,000 AUD
class IIa	3,000 AUD
class IIb and III	10,000 AUD
active implantable medical devices (AIMD)	15,000 AUD

4.2 Costs for ethics approval by ethics commissions or ethics committees

The processing fee for the HREC application is between AUD 2,000 and AUD 5,000.

Additional fees are charged for the site-specific assessments, i.e., for each participating clinic or site. Typical fees are between AUD 1,000 and AUD 3,000 per site.

There is also an annual fee for continuing the study after the first year. Expect to pay around AUD 500 to 2,000 per year per site.

Amendments during the trial will be charged AUD 500 to AUD 2,000 per amendment.

Registration of the clinical study in the Australian Clinical Trials Registry (ACTR) is free of charge.

4.3 Costs for training and recruitment

The next block of costs involves selecting and training test centers and recruiting participants.

cost item	fees (approx.)
fees for the site evaluation by the sponsor (site selection visit)	2,000 to 5,000 AUD per test center
training costs for trial personnel (physician investigator, study personnel)	5,000 to 10,000 AUD per center for initial training
annual refresher training	2,000 to 5,000 AUD per center
advertising costs for participant acquisition via various channels (print, online, TV, etc.)	very variable, between 20,000 and 100,000 AUD per study

4.4 Costs for meeting regulatory requirements

Expenses are also incurred to monitor the conduct of the study and ensure compliance with regulatory requirements.

cost item	fees (approx.)
costs for monitors who regularly visit the test centers on site	typically 1,000 to 3,000 AUD per monitor visit and test center
travel and accommodation costs for the monitors	according to effort (note distances!)
possible costs for a Contract Research Organization (CRO), which carries out the monitoring on behalf of the sponsor

4.5 Summary

The average cost of applying for clinical studies of medical devices in Australia ranges from several tens of thousands to a few hundred thousand AU dollars.

Manufacturers sometimes benefit from cost reimbursement when they submit funding applications. The NHMRC (National Health and Medical Research Council) in Australia plays an important role in allocating this funding.

The NHMRC, an expert council, is an independent legal authority that reports to the Australian Department of Health and advises the Australian Government on health and medical research issues.

5. Support

5.1 Official bodies

The TGA’s handbook on clinical studies is helpful. It provides guidance on legal and regulatory requirements as well as GCP requirements. It also describes the requirements for clinical studies with “unapproved” therapeutic goods.

The Inter-Governmental Policy Reform Group (IGPRG) facilitates the regulation and promotion of ethical research in Australia through collaboration between government agencies, National Health and Medical Research Council (NHMRC), Therapeutic Goods Administration (TGA) and Office of Gene Technology Regulator (OGTR) in conjunction with the Australian Commission on Safety and Quality in Health Care (ACSQHC).

The Australian Commission on Safety and Quality in Health Care provides resources such as the National Clinical Trials Government Framework und User Guide and consults on implementing the governance framework.

5.2 Sources

These sources are also useful

TGA

• Therapeutic Goods Act 1989 (TG Act)
• Therapeutic Goods Regulations 1990
• Privacy Act 1988

NHMRC 

• Clinical Trials Notification (link is external) (CTN) scheme
• Clinical Trials Approval (link is external) (CTA) scheme
• TGA’s Clinical Trial website
• The Australian Clinical Trial Handbook
• Australian Clinical Trials – Useful Links for Industry and Sponsors
• NHMRC’s e-learning module: Research Governance related to Clinical Trials

Links for “ethics & governance”

• NHMRC’s Human Research Ethics Application
• ICH Guideline for Good Clinical Practice (ICH-GCP) (Annotated by the TGA)
• National Statement on Ethical Conduct in Human Research 2007 (updated 2018)
• The Australian Code for the Responsible Conduct of Research, 2018
• Site Specific Assessment​

Clinical trial agreements, insurance, and templates

• Medical Technology Association of Australia
• Medicines Australia Clinical Trials Research Agreements
• Medicines Australia indemnity forms
• Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia 2014 (NHMRC)
• FAQs: Indemnity and insurance arrangements for clinical trials in Australia
• Essential Principles Checklist

6. Conclusion, summary

Australia has set itself the objective of promoting high-quality research and development of new medical therapies and devices and is attracting foreign research.

Manufacturers should, therefore, consider Australia for clinical studies. Efficient approval processes, a good infrastructure, a high level of expertise, and a diversified population make it a good choice.