Clinical trials at a glance

18 May 2001

There are two schemes under which clinical trials involving therapeutic goods may be conducted, the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme. These schemes are used for clinical trials involving:

• any product not entered on the Australian Register of Therapeutic Goods; or
• use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval.

Clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence.

The CTN Scheme is a notification scheme.

• All material relating to the proposed trial, including the trial protocol is submitted directly to the HREC by the researcher at the request of the sponsor. The TGA does not review any data relating to the clinical trial. The HREC is responsible for assessing the scientific validity of the trial design, the safety and efficacy of the medicine or device and the ethical acceptability of the trial process, and for approval of the trial protocol. The institution or organisation at which the trial will be conducted, referred to as the 'Approving Authority', gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC.
• CTN trials cannot commence until the trial has been notified to the TGA and the appropriate notification fee paid.

The CTX Scheme is an approval process.

• A sponsor submits an application to conduct clinical trials to the TGA for evaluation and comment. A TGA Delegate decides whether or not to object to the proposed Usage Guidelines for the product. If an objection is raised, trials may not proceed until the objection has been addressed to the Delegate's satisfaction.
• If no objection is raised, the sponsor may conduct any number of clinical trials under the CTX application without further assessment by the TGA, provided use of the product in the trials falls within the original approved Usage Guidelines. Each trial conducted must be notified to the TGA.
• A sponsor cannot commence a CTX trial until written advice has been received from the TGA regarding the application and approval for the conduct of the trial has been obtained from an ethics committee and the institution at which the trial will be conducted.There are two forms, each reflecting these separate processes (Parts), that must be submitted to TGA by the sponsor.
• Part 1 constitutes the formal CTX application. It must be completed by the sponsor of the trial and submitted to TGA with data for evaluation.
• Part 2 is used to notify the commencement of each new trial conducted under the CTX as well as new sites in ongoing CTX trials. The Part 2 form must be submitted within 28 days of the commencement of supply of goods under the CTX. There is no fee for notification of trials under the CTX scheme.

All CTN and CTX trials must have an Australian sponsor. The sponsor is that person, body, organisation or institution which takes overall responsibility for the conduct of the trial and signs either the CTN form or the CTX form. The sponsor usually initiates, organises and supports a clinical study and carries the medico-legal responsibility associated with the conduct of the trial.

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