Clinical_Trial_Regulatory_sites_Australia_Credevo

Australia has the world’s best researchers and health professionals, boast a world-class research infrastructure and high standards of clinical trials conduct. This leads to good quality, increased speed, and high confidence in the result.

Clinical_Trial_Regulatory_sites_Australia_Credevo

What do you call a country with quality research facilities, efficient ethics, and regulatory framework, diverse participant recruitment pool, research tax incentives, and flexibility in conducting research?

Some call it a dream destination, others Australia!

Top 5 reasons to conduct clinical trials in Australia

  1. Efficient regulatory environment
  2. Globally recognized standards
  3. Australian government incentives, benefits, investment, and support
  4. Clinical trial aware and willing population
  5. Structured documentation process. For example template clinical trial research agreements

Along with these reasons, questions may arise for those interested in Australia for conducting clinical trials, which include

  • What are the regulatory processes (hurdles?), and
  • How can we find the sites to conduct trials there?

In these articles, let’s try to address these questions.

Regulatory for Clinical trials in Australia

Regulatory authority for conducting clinical trials in Australia

Therapeutic Goods Administration (TGA) is the regulatory body in Australia. the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics.

Australian sponsor

To conduct a clinical trial in Australia, the trial must have an Australian sponsor. 

The sponsor may be an

  • Individual (for example a medical practitioner),
  • A body or organization (for example hospitals, area health services, non-government organizations), or
  • A company (for example pharmaceutical companies, CROs).

TGA would deal directly with the Australian sponsor on all matters relating to the trial.



Where to submit the trial application?

There are two major systems for submission of clinical trial proposal for therapeutic goods that have not been evaluated by the Therapeutics Goods Administration (TGA) and entered into the Australian Register of Therapeutic Goods (ARTG) for general marketing

  • Clinical Trial Notification (CTN) or
  • Clinical Trial Approval scheme (CTA) scheme (formerly known as Clinical Trial Exemption (CTX) schemes.

To submit CTNs or CTX applications, clinical trial sponsors must obtain a TGA client Identification Number (Client ID).

Clinical Trial Notification (CTN)

In this case, the scientific and ethical review should be provided by a Human Research Ethics Committee (HREC), with subsequent notification to the TGA.

Clinical Trial Approval scheme (CTA) (formerly known as Clinical Trial Exemption (CTX)

Whereas in this scheme, the TGA has a direct role in the review of trial scientific data and must give an ‘approval’ for the proposed trial program to go ahead.


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Human Research Ethics review (HREC)

  • All clinical trials in Australia require the review and approval of trial proposals by an ethics committee.
  • The ethics committee must have notified its existence to the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC) and provided assurances that it is operating within its guidelines.
  • Ethics committees in Australia provide a combined ethical and scientific review process.

Approval time for clinical trials in Australia

Human Research Ethics Committee (HREC) review takes 1-3 months (however, depends upon the institution) and CTN takes about 7-14 days.

Type of approval

The approval process for conducting a clinical trial is Parallel.

Clinical_Trial_Regulatory_Australia_Credevo

Legends: CTN- Clinical trial Notification, CTX- Clinical trial Exemption, TGA-Therapeutic Goods Administration, HREC-Human Research Ethics Committee
NOTE: HERC Review time depends upon the institution

Clinical Trial Notification (CTN) submission process

  • CTA called clinical trial Notification (CTN) can be submitted online by accessing to secure online TGA Business Services (TBS) site.
  • If the organization already has online access to TBS, it will have a Client ID without online access to TBS.
  • An administrator should be nominated via the organization details form to gain access to TBS.
  • This applies to those organizations that already have a TGA client identification number (Client ID), as well as new organizations.
  • If it does not have a Client ID then it should apply for a new Client ID.

Clinical Trial Approval scheme (CTA) (formerly known as Clinical Trial Exemption (CTX) process

The CTA scheme application procedure is currently undergoing review by the TGA. However the old process is as below.

  • A sponsor applies to conduct clinical trials to the TGA for evaluation and comment.
  • A TGA Delegate decides whether or not to object to the proposed Usage Guidelines for the product. If an objection is raised, trials may not proceed until the objection has been addressed to the delegate’s satisfaction.
  • If no objection is raised, the sponsor may conduct any number of clinical trials under the CTA application without further assessment by the TGA, provided use of the product in the trials falls within the originally approved usage guidelines. Each trial conducted must be notified to the TGA.
  • A sponsor cannot commence a Clinical Trial Approval trial until written advice has been received from the TGA regarding the application and approval for the conduct of the trial has been obtained from an ethics committee and the institution at which the trial will be conducted.

Clinical Trial Approval scheme (CTA) (formerly known as Clinical Trial Exemption (CTX) – forms

There are two forms, each reflecting separate processes (Parts), that must be submitted to TGA by the sponsor.

  1. Part 1 constitutes the formal CTX application. It must be completed by the sponsor of the trial and submitted to TGA with data for evaluation.
  2. Part 2 is used to notify the commencement of each new trial conducted under the CTX as well as new sites in ongoing CTX trials. The Part 2 form must be submitted within 28 days of the commencement of the supply of goods under the CTX. There is no fee for notification of trials under the CTX scheme.

Fee structure for clinical trials in Australia

Here are the fees/charges for various categories.

  • For prescription medicine, biological, and other listed and registered therapeutic goods CTN – $345 AUD.
  • For prescription medicine CTX for 30-day evaluation – $1,665 AUD.
  • For prescription medicine CTX for 50-day evaluation – 20,800 AUD.
  • For biological CTX – $25,200 AUD.

Applications for clinical trials under the CTX scheme cost more than notifications under the CTN scheme because of the increased work needed to evaluate the CTX application data.

Applications for clinical trials under the CTX scheme cost more than notifications under the CTN.

More information on these charges can be found on TGA Website

Click here to learn about various regulatory incentives and financial benefits provided by Australian regulatory in orphan drug development

Human Research Ethics Committees (HREC)

  • The ethics committee must have notified its existence to the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC) and provided assurances that it is operating within its guidelines.
  • Ethics committees in Australia provide a combined ethical and scientific review process,
  • HRECs have a pivotal role in clinical research in Australia because they undertake the key responsibilities of clinical trial approval and oversight
  • HRECs operates under the auspices of the Australian Health Ethics Committee.
  • Additionally, public hospitals are required to undertake a research governance step in the form of a site-specific assessment (SSA) for each project.
  • Therefore, for public sites, HREC and SSA are required for a clinical trial to commence.
  • The institution or organization where the trial will be conducted will give the final go-ahead for conducting the trial at the site, having taken into account advice given by the HREC.
  • CTN research projects must not start at a site until the research project and investigational site have been notified to the TGA and the appropriate notification fee paid.
  • It is preferable to wait for the TGA to confirm receipt of the CTN before recruitment commences.

Medical device trials

The clinical trial regulatory process for devices is essentially similar to that for medicines. Often, the protocol is sent in by the sponsor/principal investigator(s) with the CTN notification form, and in such instances comments are provided on the document by the medical advisory staff. CTX applications for medical devices are rare.

Top benefits of conducting clinical trials in Australia

Quality research and facilities

for its highly trained clinical workforce and the high-quality data produced by its experienced, trained (and accredited) research teams.

Efficient ethics and regulatory framework

Research proposals are submitted directly to Australian Human Research Ethics Committees (HRECs) which assume the primary review responsibility for ethical and scientific review.

The usual review cycle takes only 4 to 8 weeks and is based on the submission of a protocol, investigator brochure and if required, an independent toxicology report.

The diverse participant recruitment pool

Australia 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 its size.

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

Flexibility

Companies conducting clinical trials in Australia do not require the US FDA Investigational New Drug (IND) application approval.

Data output from studies carried out in Australia meets global standards and can be used to support international regulatory applications, including the US FDA IND submission. This makes the process more efficient, flexible yet ethical.

Australia offers a lot to all kinds of drug / medical device / biotech companies in terms of market expansion. It’s always interesting to consider Australia in your global strategy.


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References