Australia is viewed as being an ideal country to carry out clinical trials due to its world class research infrastructure, government commitment and excellent health professionals.
All clinical trials must be reviewed and approved by an ethics committee before commencing. The ethics committee has to make their presence known to the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC) and show evidence that it is operating within their guidelines. The Ethics Committee in Australia provides both an ethical and scientific review process and will sometimes involve external specialists when necessary.
The International Conference Harmonization (ICH) have set the standards for clinical trials worldwide (known as Good Clinical Practice), including Australia’s own Therapeutic Goods Administration (TGA). The ultimate goal for worldwide clinical trials is that they collect high quality and accurate data while protecting the confidentiality and wellbeing of all participants.
On Australian soil, The National Health and Medical Research Council (NHMRC) works alongside the Human Research Ethics Committees (HRECs) to guide them in the crucial role they play in reviewing the scientific and ethical aspects of clinical trial proposals.
Before the clinical trial is approved, some documentation must be put together which outlines the goals and logistical requirements of the trial, which will then be reviewed by the ethics committee.
The documentation includes:
Investigator’s Brochure (IB):
- Clinical and non-clinical data on the experimental products to be used in the trial.
- Risk and benefit assessment.
- Product metabolism in animals.
- Product metabolism in humans.
- Safety and efficacy.
- Previous marketing of the product.
- Summary of data and guidance for the investigator.
- Explains exactly what will be involved in the trial, (subjects, statistical considerations, study visits, stopping rules, subject withdrawal, product management, data collection, adverse reaction reporting, record keeping, finance and insurance and trial extensions.
- Patient consent and information documents.
Important questions to think about:
- What is the trial supposed to solve/What question will it answer?
- Are you able to get enough participants for the trial?
- Are the consent forms detailed enough so the participants know exactly what to expect?
- Are the products and equipment correctly labelled?
The Human Research Ethics Committees have the right to request any additional documentation that they may need. They are also entitled to perform reviews of trials to ensure that there are no risks to the participants and that the clinical trial is following all safety and ethical protocols.