AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
• once TGA approval is granted, the clinical trial sponsor must still obtain HREC approval (which will focus on scientific and ethical issues relating to the clinical trial protocol) and site governance authorisations before commencing the trial; • any significant changes to the manufacturing and quality and safety data reviewed and approved by the TGA, or any other aspect of the trial provided to the TGA with the CTA application, must be given to the TGA and may also require TGA approval; and • clinical trial sponsors should also notify the TGA of clinical trial completion after the trial has been completed at all study sites. 2.3 Public Availability of the Conduct of a Clinical Trial While the legislation does not expressly require the registration of clinical trials in Australia, the National Statement mandates that researchers must regis- ter any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes on a publicly accessible registry before participant recruitment begins. When registered, certain information about each clini- cal trial, including results after trial completion, will be made available to the public. Clinical trial registries include the Australian New Zealand Clinical Trials Reg- istry (ANZCTR), the US ClinicalTrials.gov or the World Health Organization (WHO) International Clinical Trials Registry Platform. 2.4 Use of Online Tools to Support Clinical Trials The use of digital technology – including online recruit- ment, e-consent, electronic patient-reported out- comes (ePROs), telehealth and remote monitoring – is generally permitted in clinical trials in Australia. Many clinical trial sponsors utilise these tools to recruit participants, conduct virtual trials, manage data and monitor outcomes. In using these tools, clinical trial sponsors must comply with: • good clinical practice principles;
• the Privacy Act 1988 (Cth) (including the Australian Privacy Principles (APPs) set out therein) and any relevant state/territory health privacy legislation; • the National Statement; • HREC approvals; and • site governance requirements. Given that health information is classified as sensitive information, it is subject to higher protections. All recruitment materials and processes, including online materials, require approval from the relevant HREC. Sponsors must provide clear collection notices and obtain express consent where necessary. Clinical trial sponsors must also ensure that they implement proportionate security measures to protect data and ensure that any third-party service providers comply with Australian privacy legislation. Contracts with service providers should address key aspects such as data processing, security and audit rights. 2.5 Use of Data From Clinical Trials Clinical trial datasets commonly contain personal information and often sensitive information (including health and genetic information). As a result, handling and sharing of trial data must align with the Privacy Act 1988 (Cth) (including the Australian Privacy Prin- ciples found in the Privacy Act), and any applicable state and territory health privacy legislation. For Australian law purposes, personal information is any information or an opinion about an identified indi- vidual or an individual who is reasonably identifiable . The question of whether an individual is reasonably identifiable from the information or opinion in question depends on context and the circumstances in which the information is held. For this reason, anonymised or pseudonymised trial data might still be considered personal information and therefore subject to the requirements of Australia’s privacy laws. Use and disclosure should be limited to the research purposes for which the data was collected unless a rel- evant exception applies or fresh consent is obtained. Research-specific allowances may be available under approved guidelines where consent is impracticable
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