Drugs and medicines

The Australian Cancer Trials glossary contains basic information about drugs commonly used in the treatment of cancer. It does not contain information about all drugs used in clinical trials.

If you would like to find out more information about a drug we recommend the following websites:

• NSW Cancer Institute
  The NSW Cancer Institute provides access to information relating to cancer drugs, that is listed in MIMS. MIMS is a subscriber only service that provides a database of comprehensive drug information. MIMS is updated on a regular basis. The information provided by MIMS is intended for medical professionals and is very detailed.
• The NPS MedicineWise
  The NPS presents all the most relevant and up-to-date information about medicines online including the CMIs (Consumer Medicine Information) for prescribed drugs. It also offers a Medicines Line where you can talk to a pharmacist 9 am- 5 pm, Mon.- Fri. (AET).

If the clinical trial data support the safety and efficacy of a new medicine or a new use of a medicine, an application is made to theTherapeutic Goods Administration (TGA) to have the medicine or new treatment approved for use in Australia. The TGA carries out a range of evaluations to ensure therapeutic goods are of an acceptable standard and that the Australian community has access within a reasonable time to therapeutic advances. This includes new medicines and new medical treatments. Unless exempt, therapeutic goods (either drugs or devices) must be approved by the TGA as either 'registered' goods or 'listed' goods before they may be supplied in, or exported from Australia.

If a clinical trial involves the use of a drug that is not a 'registered' or 'listed' good on the Australian Register of Therapeutic Goods, or is listed for a different use, the TGA must be notified. All clinical trial information must also be approved by a Human Research Ethics Committee who assess the ethical acceptability of the trial process and the scientific validity of the trial design. Depending on the type of drug used in the trial, the safety and efficacy of the medicine will be assessed by either the TGA or a Human Research Ethics Committee.

Medicines are added to the PBS on the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), an expert and independent advisory body of medical specialists, general practitioners, other health professionals and a consumer representative. By being listed on the PBS, drugs are made available at a subsidised rate to people who need them. The PBS provides reliable, timely and affordable access to a wide range of medicines for all Australians. For more information on the PBAC and PBS go to:  http://www.pbs.gov.au/  

The main priority for the PBAC is to consider the effectiveness and cost effectiveness (value for money) of a proposed benefit compared to alternative therapies. If it is felt the drug is of acceptable clinical and cost effectiveness, then the PBAC will recommend the drug for listing on the PBS.  A number of other processes need to be completed before the product can be PBS listed for the recommended purpose, including pricing negotiations with the manufacturer, finalisation of the conditions for listing, and consideration by the Government.  Listing on the PBS means that there may be a minimal cost to patients relative to the true cost of the drug. 

Not all drugs approved by the TGA are recommended for listing on the PBS. For consideration of listing on the PBS, a submission must be made to the PBAC.  Usually the PBAC submission is made by the manufacturer of the drug as they are usually in the best position to provide the appropriate data to support the submission. The assessment process by the TGA and listing on the PBS can take time. In some circumstances a particular drug may be available overseas before it is available in Australia.

Clinical trials can be sponsored by individuals (e.g. medical practitioners), bodies and organisations (e.g. hospital, non-government organisations) or companies (e.g. pharmaceutical companies). The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for the conduct of the trial. Drugs used in all clinical trials are required to go through the same approval process, regardless of the sponsor.

Medicines Australia represents the pharmaceutical industry in Australia through policy and government relations, administering the code of conduct, education the community and providing specialist advice.