Clinical trials for researchers

According to the National Health and Medical Research Council (NHMRC) a commercially sponsored clinical trial is funded and sponsored by a commercial company. 

The company designs the protocol and owns the results and intellectual property right arising from the trial.

According to the National Health and Medical Research Council (NHMRC) an investigator initiated clinical trial is when a non-commercial (not for profit) organisation retains control of the protocol and is the trial sponsor. 

Non-commercial trials are usually publicly funded (e.g. by government/charities), but may also be funded /supported by a commercial company.

Phase 0: (pilot studies) test how the body responds to experimental drugs on a very small number of participants. These trials use small doses of the drug on one occasion or for a short time period.

Phase 1: projects test on a small group of participants (between 20 and 80). They allow qualified researchers to test a new intervention, drug or device on humans for the first time.

Phase 2: projects test on large number of participants (around 700), this phase tests for efficacy of the intervention, drug or device and evaluates safety.

Phase 3: projects test on larger numbers of participants (can range between 700 to 7000). These projects may include control groups to gather more information on adverse effects or safety measures for the interventions, drugs or devices being tested.

Phase 4: projects occur after the intervention, drug or device is in use with the potential aim to monitor effectiveness within the general population, record adverse effects over lengthy time periods or consider use for treatment in varying medical conditions.

The Therapeutic Goods Administration (TGA) must be notified of clinical trials of unapproved therapeutic goods via a CTN.

For more information about the CTN scheme view the Australian Clinical Trials Handbook. If your study requires a CTN please contact the clinical trials team who will submit the notification for you.

Information for completing a CTN where CALHN HREC is the reviewing HREC and/or CALHN is the Approving Authority is available in the CTN information document below.

The Therapeutic Goods Administration (TGA) must be notified of clinical trials of unapproved therapeutic goods via the CTA scheme.

For more information about the CTA scheme view the Australian Clinical Trials Handbook. 

Follow the TGA instructions available on the Department of Health and Aged Care website to complete the CTA application.

Each clinical trial conducted at an SA Health site and sponsored by an external third party must be governed by a written agreement clarifying the obligations and responsibilities of the parties involved.

Every CDA must be reviewed by Central Adelaide Local Health Network (CALHN) Research Services.

The contracting party must always be Central Adelaide Local Health Network Inc and not the principal investigator. Principal investigators must not sign CDAs on behalf of CALHN.

Wherever possible, Clinical trial-related CDAs should be mutual (i.e. all parties will be sharing confidential information).

This is in order to protect any CALHN confidential information that may be shared with the clinical research organisation and/or the study sponsor.

All contracts require review by CALHN Research Services. The Research Contracts Officer negotiates contact terms regarding these agreements between various parties and CALHN including:

staff members
universities
hospitals
SAHMRI
national and international companies
intellectual Property and/or Finance (other than a grant) agreements.

Alternative clinical trial research agreement templates are available on the Medicines Australia website.

All applications must provide a detailed budget approved by the appropriate delegate.