What is a Clinical Trial?

A clinical trial is a research project undertaken to investigate the safety and efficacy of a drug or medical device. Research is conducted into new medications or therapeutic goods but can also involve products already available on the market, for further improvement.

In Australia, the Therapeutic Goods Administration (TGA) is the regulating authority and governing body for the approval of new drugs and therapies. Therefore, any 'unapproved therapeutic goods', which are considered experimental are required to make use of the Clinical Trial Notification (CTN) scheme or the Clinical Trial Exemption (CTX) scheme. Both schemes provide an avenue for lawful access to and supply of products not yet accepted in the general market. In New Zealand, the Ministry of Health (Medsafe) is the regulatory authority which administers the approval process for clinical trials using investigational medicinal products which are not approved for use in New Zealand. Clinical trials on medical devices or medicines, which are approved for use in New Zealand, do not require Ministry of Health (Medsafe) approval.

The standard of clinical trials in Australia and New Zealand is also guided by a set of principles and guidelines developed by the International Conference of Harmonisation (ICH). These principles have their origins firmly in the World Medical Association Declaration of Helsinki and exist to protect the safety and rights of all clinical trial participants. The principles advocate the collection of credible and high quality data whilst minimising risk or harm to patients.

In Australia, the National Health and Medical Research Medical Council (NHMRC), also play an important role in the conduct of clinical trials. The NHMRC hold a major role in advising and guiding Human Research Ethics Committees (HREC's), which is responsible for reviewing the 'ethical' and 'scientific' aspects of a clinical trial. HREC's are also responsible for the monitoring of clinical trials once approved.

In New Zealand the Health and Disability Ethics Committee (HDEC) administers the ethics approval system, which applies to all clinical trials conducted in New Zealand. Participating in research should be voluntary. It is important that people never feel forced to take part in a trial. Researchers are required to obtain 'Informed Consent' from patients prior to undertaking any study related procedures. This means that patients should have a clear understanding of the trial objectives and the potential benefits and risks associated with the treatment before signing and consenting to enrol. Patients should feel free to discuss their involvement with family or their local GP, and should never feel as though their decision to not participate in a trial will compromise the quality of their future healthcare. Never take part in anything that makes you feel uncomfortable or that you don't understand.

Patients should be aware of the guidelines that exist to protect them. Further information on guidelines for the conduct of clinical trials can be obtained from the TGA, NHMRC, Medsafe and HDEC.

In order to further protect patients/participants' personal information CTC has adopted a Privacy Policy in compliance with its obligations under the Information and Privacy Act 2000 (Vic).

Glossary of terms

Last Updated 15/01/2016