What is a clinical trial?
The World Health Organisation's (WHO) definition for a clinical trial is 'any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes'. Clinical trial interventions include, but are not restricted to:
- Experimental drugs
- Medical devices
- Surgical and other medical treatments and procedures
- Psychotherapeutic and behavioural therapies
- Health service changes
Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
Clinical trials and the Therapeutic Goods Administration
Clinical trials are needed to collect data required by the Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health and Ageing that is responsible for ensuring that healthcare products available in Australia are safe and effective.
Therapeutic goods must be entered into the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in or exported from Australia, unless they are exempt or otherwise authorised by the TGA.
The TGA enter therapeutic goods into the ARTG when:
- Higher risk therapeutic goods have been assessed as meeting the requirements for quality, safety, and where appropriate, efficacy and/or performance; or
- Lower risk medicine, biological or medical device applications have been validated
Goods which have not been evaluated by the TGA for quality, safety and efficacy, and entered into the ARTG for general marketing, are referred to as 'unapproved goods', because such products are considered experimental, and do not have general marketing approval. These include:
- Any product not entered into the ARTG; or
- Use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval
There are several schemes under which 'unapproved goods' may be lawfully supplied.
Ethical Review and Research Governance Procedure for all Early Phase Clinical Trials at Barwon Health
To adopt current best practice in Victoria, and as a complement to current standard ethical review and research governance, the following document outlines a procedure for all Early Phase Clinical Trials (Phase 1) at Barwon Health.
Important Update from the TGA
A new online form is now available for the Clinical Trial Notification (CTN) Scheme. As of the 1st of July 2016, the TGA will no longer accept paper versions of the CTN forms. All applications to the TGA must now be submitted electronically. Guidance material for the new online CTN form is available on the TGA website.
This is a welcome initiative and will enhance the efficiency of governance aspects of clinical trials in Australia. Please click here for further information.
For Sponsors submitting eCTNs for clinical trials being conducted at Barwon Health, the approving authority information is provided below:
Name of Approving Authority: Barwon Health, University Hospital Geelong
Barwon Health HREC Code: EC00208
Approving Authority Contact Officer: Ms Lisa Fry
Position: Research Governance Officer
Contact Phone: (03) 4215 3373
Contact Email: email@example.com
For projects approved by the Barwon Health HREC, the HREC contact information is provided below:
HREC Name: Barwon Health Human Research Ethics Committee
Barwon Health HREC Code: EC00208
HREC Contact Officer: Mr Richard Larsen
Position: Research Ethics Officer
Contact Phone: (03) 4215 3371
Contact Email: firstname.lastname@example.org
Please email email@example.com to provide any feedback which will help to continually improve this new format.
The Clinical Trial Notification (CTN) Scheme is a notification scheme, and over 95% of all trials are approved via this route. Where a HREC bears the responsibility for approving:
- The safety and efficacy of the medicine or device
- The ethical acceptability of the trial process
- Approval of the trial protocol
- Evaluating the scientific merit of the trial
The CTN is required when a clinical trial investigates the use of a product in Australia which is either:
- Not on the Australian Register of Therapeutic Goods (ARTG)
- On the ARTG, but being used outside the conditions of its marketing approval
The TGA does not review any data relating to the clinical trial, but acknowledges the trial in writing within ten days of receipt of the signed CTN form and appropriate payment.
A separate CTN form must be completed for each potential trial site. It is standard for all fees to be reimbursed to the CRO by the Sponsor as part of the trial budget. CTN trials cannot commence until the TGA has been notified of the trial, and the appropriate notification fee has been paid.
The Clinical Trial Exemption (CTX) Scheme is rarely used in Australia but is a modified approval process by which a Sponsor submits an application to conduct a clinical trial to the TGA for evaluation and comment. A TGA delegate then decides whether or not to object to the proposed usage guidelines for the product.
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 a HREC at each institution where the trial will be conducted.
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 HREC before the trial may commence.
Clinical trial Sponsors
The Sponsor is the individual, company, organisation, or institution that:
- Intends to supply the goods
- Initiates, organises and supports a clinical study
- Takes overall responsibility for the conduct of the trial
- Signs either the CTN or CTX form
- Is responsible for meeting the regulatory requirements of the Therapeutic Goods Legislation
All CTN and CTX trials must have an Australian Sponsor. For more information about the Sponsor's responsibilities, please see the Australian Clinical Trial Handbook.
Clinical trials can be divided into two groups, according to the type of Sponsor:
- The typical industry-sponsored clinical trial, where the trial is conducted by a private entity (who is commonly the holder of the 'marketing approval' of the trial product)
- The investigator initiated trial where the Sponsor is not a commercial entity, but an individual health professional or a 'not-for-profit organisation', which can be a governmental body (e.g. a public institution hospital, University, a trust, or a research group) - also called a NCT (non-commercial trial)
The responsibilities of a trial Sponsor, with respect to Good Clinical Practice (GCP), are extensive and are detailed in Item 5 of the Note for Guidance on GCP.
Good Clinical Practice (GCP)
All clinical trial research conducted under the auspices of Barwon Health and all research conducted in Australia, must comply with the Australian adopted version of ICH-GCP Guidelines.
The Note for Guidance on GCP (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording, and reporting of clinical trials.
The TGA has adopted CPMP/ICH/135/95 in principle, but has recognised that some elements are, by necessity, overriden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements'.
Failure to conduct research in line with GCP guidelines contravenes the Australian regulatory framework and increases exposure to risk.
Barwon Health requires investigators on clinical trials to hold current GCP Certification which meets the minimum criteria required, and appears on the recognised list of courses and training providers on the TransCelerate Biopharma Inc website. The REGI Unit recommends GCP training courses offered by ARCS Australia.
TGA fees for the CTN scheme are currently AUD$320.00 for each notification. A notification can be made for all sites participating in the trial simultaneously, or several notifications can be made for sub-groups of sites. A notification fee applies for each single notification. The fee for a CTX 50 day review is AUD$19,400.00 (review of chemical, pharmaceutical and biological, pharmaco-toxicological and clinical data). The fee for a 30 day review is AUD$1,560.00.
There are also a number of ways that patients can gain access to products that have not been approved for use in Australia:
- Authorised Prescribers - the TGA is able to grant medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients
- Special Access Scheme - the Special Access Scheme refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis
How to prepare a clinical trial application
For all clinical trials, please submit the following to the REGI Unit, as applicable:
- A copy of the Investigator's Brochure
- Evidence of GCP Training by Principal Investigator
- A CTN or CTX form
- Three original copies of the applicable Clinical Trial Research Agreement (CTRA) signed by the Sponsor and Principal Investigator (for drug trials only)
- Three original copies of the MTTA Standard Clinical Investigation Research Agreement (CIRA) signed by the Sponsor and Principal Investigator (for device trials only)
- Insurance certificate (for commercially sponsored clinical trials only - this should comply with the requirements for clinical trial's insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals)
- Two original copies of each the Standard Medicines Australia Form of Indemnity for Clinical Trials and HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials (for commercially sponsored drug trials only)
- Two copies of each the Standard Medical Technology Association of Australia Form of Indemnity for Clinical Investigation and HREC Review Only Medical Technology Association of Australia Form of Indemnity for Clinical Investigation (for commercially sponsored device trials only)
Please note: For all CTRAs and CIRAs to which Barwon Health is a party, complete the 'Institution' details on Page 1 as follows:
Name: Barwon Health
Address: Ryrie Street, Geelong VIC 3220
ABN: 45 877 249 165
Contact for Notices: Director of Research
Phone Number: (03) 4215 2032
Please note: For all indemnities given by Sponsors to Barwon Health, please complete the 'To' or 'the Indemnified Party' section on Page 1 as follows:
Name: Barwon Health
ABN: 45 877 249 165
Address: Ryrie Street, Geelong VIC 3220
The Sponsor or Barwon Health Principal Investigator (for Barwon Health investigator initiated projects) sends the completed CTN to the TGA.
CTN Acknowledgement should be sent to RGO once received by emailing firstname.lastname@example.org.
Clinical trial governance submission
Prior to submitting your application, a Barwon Health Reference Number is required - please refer to the How to prepare an application webpage for instructions on how to obtain a reference number.
- Please refer to the Multi-site applications webpage for instructions on what is required for a governance application for a multi-site clinical trial
- Submit the complete electronic version (including the CTN, agreement, indemnity, insurance certificate, etc.) of your research governance/site specific assessment application by emailing email@example.com
- Submit the signed hardcopy agreement and indemnity to the REGI Unit, Level 2 Kitchener House, University Hospital Geelong, Geelong VIC 3220 (please ensure that these hardcopy documents contain original signatures)
- Research governance/site specific assessment applications can be submitted at any time - ideally, they should be submitted well before, or at the time of, the relevant ethics submission to the HREC.
Last Modified: Monday, 13 May 2019