Sponsoring a clinical trial in Australia

All clinical trials conducted in Australia must have a trial sponsor that is an Australian entity. Find out who can sponsor a clinical trial and what they are responsible for.

Who can sponsor an Australian clinical trial

International pharmaceutical and biotechnology companies and groups of researchers can conduct a clinical trial in Australia. However, an Australian entity must sponsor the trial. Clinical trial sponsors can be:

  • commercial companies
  • collaborative research groups
  • government entities, including health service organisations
  • an individual investigator
  • a university.

Types of sponsors

The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for running the trial.

A wide range of organisations conduct, or sponsor, clinical trials. They include:

  • pharmaceutical companies, either solely or jointly with other research institutions such as universities and hospitals
  • private research organisations under a grant from the National Health and Medical Research Council or from public donations
  • publicly funded research organisations such as universities and teaching hospitals.

Any clinical trial must follow the Australian Government’s guidelines for ethical and good clinical practice, regardless of who is sponsoring it.

The sponsor of the trial is defined as either:

  • the investigator who has initiated and organised the trial
  • the investigator’s institution, for example hospital, research institute or university.

This can happen when another party provides the medicinal product or device used in the clinical trial, but does not run the trial. The other party is usually a pharmaceutical or medical device company.

Responsibilities of a clinical trial sponsor

The trial sponsor is responsible for starting, managing and financing, or arranging the financing of the trial. The sponsor is also responsible for:

  • obtaining appropriate approvals prior to the commencement of the clinical trial
  • adhering to conditions of any approvals during the clinical trial
  • applying the ethics principles of research merit and integrity, justice, beneficence and respect to the conduct of clinical trials
  • handling medico-legal risks.

It is often a commercial company or other organisation that initiates, organises and supports a clinical trial and carries the medico-legal responsibility associated with the conduct of the trial. Authorisation of the trial depends upon the company or organisation providing:

  • an indemnity
  • evidence that it is covered by appropriate insurance arrangements for the conduct of the clinical trial.

You can find more information about:

Date last updated:
  • Running clinical trials