AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
• the National Statement on Ethical Conduct in Human Research (the “National Statement”) issued by the National Health and Medical Research Council; • relevant Good Clinical Practice (GCP) guidelines, including the International Council for Harmonisa- tion (ICH) GCP Guideline for medicines and bio- logicals; and • principles based on the Declaration of Helsinki. Clinical trials must be conducted in accordance with a Protocol approved by a Human Research Ethics Committee (HREC), which will also be responsible for monitoring the conduct of the trial at each study site. A clinical sponsor, which must be an Australian entity, will take on the obligations of running the trial, includ- ing making any notification or application to the TGA under the CTN and CTA pathways. Clinical trials that do not involve the use or supply of unapproved prod- ucts do not need to follow the CTN or CTA pathways but will still require HREC supervision. State and territory laws, and institution-based rules, should also be taken into account. Importantly, together with the industry body for innovative medi- cines, Medicines Australia, the National Clinical Trial Agreement (NaCTA) Panel (comprised of representa- tives from all states and territories) has developed five Clinical Trial Research Agreements that are available for use by any sponsor and/or institution for specific types of clinical trials. Certain institutions (eg, public hospitals) conducting clinical trials will insist on using these Agreements without amendment. 2.2 Securing Authorisation to Undertake a Clinical Trial The clinical trial sponsor must determine whether a clinical trial will proceed under the CTN or CTA path- way, based on the risk profile of the investigational product. The choice of pathway must also be con- firmed by the HREC. The main difference between the pathways is the level of TGA review before the clinical trial commences. The CTA pathway is typically used for higher-risk or novel treatments such as gene therapy, where there is no or limited knowledge of safety associated with the product. The CTN pathway can be used for all other
studies, but will usually be appropriate where there is already some pre-clinical data supporting the safety of the device in humans. Studies involving Class 4 bio- logicals must use the CTA pathway unless evidence from previous clinical use supports the use of the bio- logical or a national regulatory body with comparable regulatory requirements has approved a clinical trial for an equivalent indication. The TGA has recently been undertaking a review of the CTA pathway, including in relation to the focus for review of the TGA compared to the HREC. This review is ongoing. CTN Pathway The CTN scheme is a notification scheme. The TGA does not review or evaluate any data relating to the clinical trial. Under the CTN pathway: • the clinical trial sponsor obtains HREC approval and site governance authorisations; • the clinical trial sponsor submits an online notifica- tion to the TGA and pays the applicable fee; • any variations to the information submitted as part of the CTN form during the clinical trial must also be notified to the TGA; and • the clinical trial sponsor should submit further notification to the TGA once the clinical trial activity relating to the supply of unapproved therapeutic goods is complete. CTA Pathway The CTA scheme is an approval scheme. The TGA will review manufacturing, safety and quality data, includ- ing any relevant pre-clinical or early clinical data that may be available, even if limited, to conduct a risk- benefit analysis that will inform their decision about whether to approve the trial. Under the CTA pathway: • the clinical trial sponsor submits an application to the TGA for evaluation and approval of the inves- tigational product’s use in the trial, and pays the applicable fee;
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