Clinical trial sponsorship
All clinical trials conducted in Australia must have an Australian entity as the nominated sponsor. For clinical trials involving an ‘unapproved therapeutic good’, the sponsor must submit a Clinical Trial Notification (CTN) form to the Therapeutic Goods Organisation (TGA) or apply via the Clinical Trial Application (CTA) scheme for approval before the trial commences. The CTN scheme is most commonly used while the CTA scheme is mandatory for specific circumstances such as a trial of a class 4 biological. This guidance will refer to CTN clinical trials.
Unapproved therapeutic goods
An unapproved therapeutic good is one which is:
- Not included in the Australian Register of Therapeutic Goods (ARTG)
- Included in the ARTG but used in a manner that is not covered by the existing entry in the ARTG
For medicines, this includes new formulations, strengths, sizes, dosages, indications, directions for use or type of contained. For medical devices (including in vitro diagnostic devices (IVD)) this includes any new manufacturers, device nomenclature system code, classification, unique product identifiers (for certain classes of medical devices or specific circumstances for in-house IVD. Specific conditions also apply to Biologicals. See more information about unapproved therapeutic goods.
An ARTG entry applies to a specific sponsor. Therefore, if the same or similar product is imported or supplied by another sponsor it is considered an unapproved therapeutic good.
Under Australian therapeutic goods legislation, a CTN is required to lawfully import or supply an unapproved therapeutic good for a clinical trial. Clinical trials not involving an unapproved therapeutic good can proceed in accordance with normal ethics and governance review processes and do not require a CTN.
CTN clinical trial sponsorship
In accordance with ICH-GCP, the sponsor of a clinical trial is the organisation that takes responsibility for the initiation, management and arrangement of financing of a clinical trial. In practical terms, this is often the organisation who conceptually designed the study, is the administering institution of grant funding or holds the intellectual property rights for the investigational product. For those undertaking clinical trials for their higher degree, the sponsor in most cases will be the academic organisation through which the student is enrolled.
Significant responsibility comes with being the nominated sponsor of a CTN clinical trial, as they hold overall responsibility for the trial, including regulatory and legal responsibility. There is also a legal requirement for the sponsor to ensure that the clinical trial is conducted in compliance with ICH-Good Clinical Practice (GCP).
Metro North Health may act as the sponsor of an investigator-initiated CTN clinical trial where specific approval has been granted by the Metro North Executive Director Research (or delegate). All requests for Metro North Health to act as a sponsor must be assessed for feasibility and will not be supported where sponsorship is deemed not feasible.
Metro North sponsorship of an investigator-initiated CTN clinical trial
In accordance with the Metro North Research Policy, formal approval of Metro North sponsorship of a CTN clinical trial must be granted by the Metro North Executive Director Research (or delegate) prior to HREC approval. A Metro North investigator or other Metro North employee cannot grant this approval.
Application and approval of clinical trial sponsorship by the Metro North Executive Director Research (or delegate) must occur before HREC submission. Metro North sponsored CTN clinical trials must submit their HREC application to the Metro North HREC. Sponsorship requests must be received at least 6 weeks before HREC closing date, to allow time for Metro North Research review and delegate consideration.
Requests for sponsorship will only be considered through submission of the Application Form, together with the following supporting documents on the required Metro North clinical trial templates:
- Draft Clinical Trial Protocol, on the Metro North Clinical Trial Protocol template with a version and date;
- Draft Investigator Brochure (IB)*1/Product specifications;
- Details of Investigational Medical Product (IMP)/Investigational Medical Device (IMD), ensuring appropriate adherence to TGA manufacturing standards;
- Budget including evidence of sufficient trial funding and the funding source (e.g. grant funding letter);
- Completed Metro North Clinical Trials Risk Assessment template;
- Evidence of statistical review by Metro North contracted service (To submit requests, https://www.qimrb.edu.au/statistical-services);
- Evidence of current GCP R3 training;
- Evidence of product availability in Australia;
- A minimum of 3 suggested discipline specific and/or clinical trial experts who can comprise a Data Safety Monitoring Board (DSMB) and/or serve as a Medical Monitor (as deemed required, following sponsorship review). Additionally, an administrative secretariat from the department, but not involved in the clinical trial, must be nominated by the research team;
- Other Supporting Documentation.
Templates are available for download within the sponsorship application form or can be provided to Metro North staff by contacting MetroNorthResearch-ClinicalTrials@health.qld.gov.au
If approval of CTN clinical trial sponsorship by the Metro North Executive Director Research (or delegate) is granted, the CTN must be submitted via the TGA business services system by the clinical trials team within the Office of Research. Access to the TGA portal will not be granted to individual trials teams/members.
Submit Metro North Sponsorship Application form