Australia currently accounts for less than 3% of global clinical trials (as logged in https://clinicaltrials.gov) and yet is a unique and attractive location for trials for several reasons. Something the Australian government is hoping to capitalise upon with a number of specific “Clinical Trial Initiatives.”
Australia is the world’s sixth-largest country by area and yet with a population of just under 29 million, is home to only 0.4% of people. It is the world’s flattest and driest inhabited continent with the oldest soils. Despite this, it is only second in the world (behind Switzerland) in terms of average wealth of the population.
Australia has the third- and seventh-highest life expectancy of males and females, respectively. It also has the highest rates of skin cancer in the world, while cigarette smoking is the largest preventable cause of death and disease, responsible for around 8% of the total mortality and disease.
To put some of this into perspective, the US is home to 4.5% of the world’s population and yet a massive 44% of clinical trials. Even in areas like skin cancer, Australia still only has less than 4% of global trials.
The Australian Government has several initiatives intended to change this situation and make the nation a much more attractive location for drug trials. A key focus is on streamlining processes such as ethics approval, governance and the pre-registration and approval of “clinical trials ready” sites.
Good clinical practice plays a vital role in Australia and is based largely on the ICH rules – but with some significant differences, all of which are detailed in Whitehall Training’s new course ICH GCP Adapted for Australia.
Some of the key features of Australian GCP are -
Ethics committees…
All human research conducted in Australia must be carried out in accordance with the Australian Code for Responsible Conduct of Research. It must also be ethically reviewed in accordance with the National Statement on Ethical Conduct in Human Research (2007 - updated May 2015).
Most human research that involves more than low risk needs to be reviewed by an HREC (Human Research Ethics Committee). Trials involving clinical interventions, such as drug trials, must always be reviewed by an HREC.
HRECs must keep records of all their transactions and let the CA review them if requested. In practice, many Australian HRECs keep records almost indefinitely (5-7 years after the completion of trials) but HRECs should check the National Statement before disposing of records.
Informed consent…
Australia has a number of additional rules covering the considerations that should be taken when seeking informed consent from particular groups.
These are –
- Pregnant women (and their unborn foetuses)
- Children and young people
- People in unequal or dependent relationships – ie where one party has or has had a position of influence or authority over the other
- Subjects with mental impairment
- Subjects highly dependent on medical care
- Subjects who may be involved in illegal activities
- Aboriginal and Torres Strait Islander peoples
- People in other countries.
Approval for trials…
Clinical trial applications in Australia are made under either the CTN (Clinical Trial Notification) scheme or the CTX (Clinical Trial Exemption) scheme.
The CTN scheme is designed to combine rapid approval of clinical trial protocols with ongoing monitoring and supervision by HRECs acting in accordance with nationally agreed guidelines developed by the NHMRC (National Health & Medical Research Council). All material relating to the proposed trial, including the trial protocol is submitted directly to the HREC by the researcher at the request of the sponsor. The TGA (Therapeutic Goods Administration) does not review any data relating to the clinical trial.
Under the CTX scheme, a sponsor submits an application to conduct clinical trials to the TGA for evaluation and comment. In the case of clinical trials of medicines, the TGA reviews the information about the product provided by the sponsor, including the overseas status of the medicine, proposed Usage Guidelines, a pharmaceutical data sheet, a summary of the preclinical data and clinical data. The scheme mirrors the scheme in place for the regulation of clinical trials of medicines in the UK.
Australia is an interesting trial location to consider, made even more so by government incentives. With the publication of ICH GCP Adapted for Australia to guide investigators through the specific of the regulatory system, the time has never been better to consider Australian drug trials.
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