Clinical trials at a glance
There are two schemes under which clinical trials involving unapproved therapeutic goods may be conducted, the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme.
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- What is an unapproved good?
An 'unapproved therapeutic good' includes:
- any medicine not entered on the Australian Register of Therapeutic Goods (ARTG), including any new formulation, strength or size, dosage form, name, indications, directions for use or type of container of a medicine already in the ARTG
- any medical device not entered in the ARTG, including any new design specification, model, technology, material or treatment modality of a medical device already in the ARTG
- any biological not entered in the ARTG:
- including any new applicable standards, intended clinical use or principal manufacturer of a Class 1 or 2 biological already in the ARTG
- including any new product name, dosage form, formulation or composition, therapeutic indication, type of container or principal manufacturer of a Class 3 or 4 biological already in the ARTG
- a therapeutic good already in the ARTG that is used beyond the conditions of its marketing approval including labelling.
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 choice of which scheme to follow (CTN or CTX) lies firstly with the sponsor and then with the Human Research Ethics Committee (HREC) that reviews the protocol. A determining factor for a HREC may be whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product.
To conduct a clinical trial in Australia, the trial must have an Australian sponsor. The sponsor may be an individual (for example a medical practitioner), a body or organisation (for example hospitals, area health services, non-government organisations), or a company (for example pharmaceutical companies, Contract Research Organisations (CROs)). TGA would deal directly with the Australian sponsor on all matters relating to the trial.
To submit CTNs or CTX applications, clinical trial sponsors must obtain a TGA client Identification Number (Client ID). Information on how to obtain a client ID is available from TGA Business Services.
Complete CTN/CTX submissions will attract a fee. The Schedule of fees and charges webpage lists the current fees and charges.
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.
- The determination of whether a CTN is required rests with the sponsor in consultation with the HREC overseeing the trial.
- 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.