A 'clinical trial' is the name commonly given to research in which a therapeutic, preventive or diagnostic intervention is tested. Clinical trials are conducted in accordance with ethical guidelines and in certain circumstances in accordance with legislation.
World Health Organisation Definition
According to the World Health Organisation (WHO), a clinical trial is ' Any research project that prospectively assigns human participants or groups to one or more health-related interventions to evaluate the effects on health outcomes.'
About Clinical Trials
The terms 'clinical trial' and 'clinical research' are often used interchangeably but frequently 'clinical trial' is used to refer to the use of a drug or a medical device ie. a 'therapeutic good' which is subject to the Therapeutic Goods legislation. This legislation is administered by the Therapeutic Goods Administration (TGA). Sometimes complementary medicines are considered to be therapeutic goods for the purposes of the legislation.
Hence, clinical trials are conducted in accordance with ethical guidelines and, in certain circumstances, in accordance with legislation. There are also international guidelines which may apply.
Clinical Trials in Australia
On 11 October 2012, the Minister for Health and Ageing and the Minister for Industry and Innovation launched australianclinicaltrials.gov.au – a consumer friendly clinical trials website which will help put potential research participants and patients in contact with clinical trial researchers. Australianclinicaltrials.gov.au includes a range of information for consumers and researchers on the conduct of clinical trials in Australia, including the benefits of participating and some questions to ask of the research team before deciding to take part.
Please visit the Australian Clinical Trials website.
The primary ethical guideline for clinical trials is the National Statement on the Ethical Conduct Human Research (2007).
Researchers conducting clinical trials should also refer to the Australian Code for the Responsible Conduct of Research.
Researchers proposing a multi-centre clinical trial should also refer to the information on the National Approach to Single Ethical Review (the National Approach), formerly known as the Harmonisation of Multi-centre Ethical Review (HoMER) Initiative. Information on the National Approach is available on the Human Research Ethics Portal.
The TGA produces a number of useful documents for researchers and HRECs. These are located on the Unapproved Therapeutic Goods section of the TGA website.
A clear and concise description of the role and responsibilities of HRECs in relation to the supply of unapproved therapeutic goods is found in Human Research Ethics Committees and the Therapeutic Goods Legislation.
The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The TGA has adopted CPMP/ICH/135/95 in principle but has published an annotat ed version for the Australian regulatory context.
The following documents provide a detailed description of the regulation of the supply of unapproved therapeutic goods:
- Access to Unapproved Therapeutic Goods - Clinical Trials in Australia
- Access to Unapproved Therapeutic Goods - the Special Access Scheme
- Access to Unapproved Therapeutic Goods - Authorised Prescribers
- Access to Unapproved Therapeutic Goods - Personal Importation
- A consolidation of all the documents in the series - Access to Unapproved Therapeutic Goods in Australia