Overview

Victoria is the premier location for research and clinical trials in Australia. This state is recognised as an international leader in clinical trials and research. Human research is important to advance scientific knowledge and improve patient care. Research can generate medical interventions that are evidence-based and provide optimal medical treatment to deliver high-quality healthcare. This encompasses a wide range of disciplines including clinical trials, clinical research, registries, health and social sciences.

The Victorian Government has implemented a streamlined ethical review process to:

• provide a faster, more efficient process for conducting health and medical research at multiple sites
• provide cost-effective healthcare through health and medical research that generates evidence on the most effective medical treatment for patients
• speed up therapeutic product development aimed at world markets
• improve delivery of new medical treatments to patients early in the development of innovative approaches for medicines, medical devices and biologicals.

Streamlining Clinical Trials and Research framework in Victoria

The Victorian Framework to streamline clinical trials was implemented in 2009 to provide single ethics review for multicentre clinical trials to reduce duplication of review and slowness to gain ethics approval at multiple clinical trial sites.

In 2015 this framework was extended to include health and medical research projects, providing single ethics review for all research projects across Victoria.

This streamlined framework enables one ethics approval no matter how many sites participate in a multicentre clinical trial or research project. Additional sites may be added under a single ethics project approval more quickly and efficiently through an ethics amendment process.

The framework has a centralised Coordinating Office for Clinical Trials and Research (Coordinating Office) located in the Department of Health (DH), Melbourne. The Coordinating Office provides support for the research sector on regulatory requirements such as ethics, site specific assessment/research governance, policy and guidance.

All public health services have a Human Research Ethics Committee (HREC) and review single site clinical trials and research. There are 22 Victorian public health services that have signed a memorandum of understanding to accept the review of one of seven Human Research Ethics Committees (HRECs) accredited in Victoria. The multicentre reviewing HRECs are also certified by the National Health and Medical Research Council (NHMRC).

The framework is underpinned by an information management platform, Ethics Review Manager (ERM). ERM is openly accessible to researchers and is used to create an ethics application, submission for ethics review, and for post ethics approval reporting or amendments. ERM holds all information throughout the lifecycle of each project.

From an ethics application a site specific assessment/research governance application for each participating site can be created. For more information go to Ethics Review Manager where ERM training for applicants includes: Applicant user guide to ERM, videos and quick tips.

Full instructions for applicants can be accessed here in the Ethics Application area. Stepwise information can be found to guide the applicant in preparing an ethics application for submission. Similarly, information is available for SSA/Research Governance Application.

Scope of the streamlined ethical review system

The Streamlining framework ensures that a single ethical review occurs for all research projects. Some projects occur at one site only, but others have multiple sites conducting a project under one ethical approval.

National guidance for human research is provided by the National Health and Medical Research Council (NHMRC). Ethical and scientific review of multicentre research projects applies to any form of human research, as defined in the National Statement on Ethical Conduct in Human Research (2007) (or any replacement of that document published by the NHMRC).

An application must be made to a human research ethics committee for the purpose of conducting research at a public health organisation. This includes low and negligible risk review.

All research projects require both ethical approval and research governance/SSA authorisation. Authorisation must occur at each organisation conducting the research before the project can commence.

In Victoria, research applications are made via Ethics Review Manager (ERM ) an online information management platform. Note that an ethics application must be created before accessing a research governance SSA form.

Overview of regulation of research involving humans

Ethical review is a formal process to ensure patient care or research proposals conform with ethical standards.

Multi-site research projects in Victoria are required to have one ethical and scientific review conducted by a human research ethics committee (HREC). Guidance on human research ethics is set out in the National Statement on Ethical Conduct in Research 2023.

Each site involved with the research project must conduct its own research governance authorisation before the project can commence; the site specific assessment (SSA) form is used to address research governance.

All research projects require both ethical approval and research governance/SSA authorisation. Organisations conducting the research project must provide authorisation for the project to commence at that site.

Applications are made via the ERM website . Note that the ethics application must be created before accessing the research governance SSA form.

The Therapeutic Goods Administration (TGA) is the Australian regulator of therapeutic goods. Clinical trials are conducted for new therapeutic goods and trials contribute to the data and information provided by the sponsor to the Therapeutic Goods Administration (TGA) when applying for inclusion of a ‘good’ on the Australian Register of Therapeutic Goods (ARTG), for use in Australia and for access to treat patients.

The TGA Australian clinical trial handbook, August 2021, Australian Clinical Trial Handbook describes the requirements and responsibilities of an ethics committee to review clinical trials of unapproved therapeutic goods before a clinical trial can commence. The TGA administers two schemes that allow for the importation into and/or supply in Australia of ‘unapproved’ therapeutic goods for use in a clinical trial. These are the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.

The CTN scheme is used for various phases for a drug (e.g. Phase III, Phase IV), medical device (e.g. pivotal study, post-market study) and bioavailability/bioequivalence clinical trials for medicines and biologicals. The CTN scheme can be used for early phase clinical trials if an ethics committee can access adequate expert scientific and clinical review. Otherwise, the CTA scheme is available for high risk studies or novel treatments such as gene therapy. CTA may be mandatory for certain products. For medical device trials the CTA scheme should be considered where the experimental device involves elements that have not been previously evaluated in clinical trials.

Locate your trials and research in Victoria

Clinical trials play a vital role in providing new treatments for better health outcomes as well as contributing to the economy.

Victoria has a strong reputation world-wide as a destination for commercially sponsored clinical trials due to a skilled workforce, quality infrastructure, a diverse population for patient recruitment and a favourable regulatory system that is supported by the Victorian Streamlining Framework.

A vast majority of Victoria’s clinical trials are conducted in metropolitan Melbourne due to location of tertiary hospitals, expertise and population density. The Victorian government is supporting the increase in capability for rural and regional Victoria to conduct and participate in clinical trials as a priority so that all Victorians can benefit. It is important to ensure rural populations are able to access clinical trials and research studies for the best medical treatments.

The Clinical Trial Research Support Service (CTRSS) was established at five rural/regional hospitals in 2019 and has attracted new clinical trials over a two-year pilot period. This model has involved organisations becoming ‘trial ready’ though establishing organisation-wide awareness of the importance of research and clinical trials. The key elements addressed are: training and advising staff, communications, organisational facilitation, governance, process support, clinical expertise, feasibility, patient recruitment, quality assurance and auditing of clinical trials.

The Coordinating Office for Clinical Trial Research (Coordinating Office) has led the CTRSS pilot program and engaged with commercial industry sponsors and Contract Research Organisations to raise awareness that rural/regional Victoria is growing clinical trial capability.

Features of clinical trials and research in Victoria

Victoria is a world-class life sciences and leading medical research centre of excellence. Victorian government investment over the past 20 years has ensured a well-positioned environment for clinical trials and health and medical research.

An initiative to streamline clinical trials and research, commenced in 2009 to reduce duplication and timelines for regulatory processes. This has enabled single ethics review of multi-site clinical trials/research projects.

Victoria operates a 30-working day benchmark for single ethics review of multicentre clinical trials and this is met at levels up to 75%. There are seven metropolitan public health organisations providing single ethical review for research.

Clinical trials are an important part of research activity in Victoria both commercial industries based and non-commercial: collaborative group, investigator-initiated, institution and university sponsored.

As of July 2024 there are:

2,092 Active commercially sponsored clinical trials in Victoria

2,548 Active commercially sponsored clinical trial study sites

1,521 Active collaborative group, investigator-initiated, Institution/university trials

2,144 Active clinical trial study sites (Collaborative group, investigator-initiated, institution and university)