In 2019, through the support of Department of Health & Human Services (DHHS), the Clinical Trial Research Support Service (CTRSS) was established at Northeast Health Wangaratta (NHW). The CTRSS is located in the Margaret Boyd Education Centre at NHW.
2022 saw the extension of the CTRSS program with Department of Jobs, Precincts & Regions (DJPR) and the establishment of the CTRSS Australian Teletrial Program (CTRSS-ATP). With support from the Medical Research Future Fund (MRFF) via Queensland Health, our aim is to improve and increase the delivery of clinical trials and teletrials to rural, regional and remote areas of Victoria.
NHW CTRSS Profile 01 February 2024 | Download PDF
NHW has established a Clinical Trials Research Support Service (CTRSS). The aim of the service is to assist with all aspects of the clinical trial process including:
The Clinical Trials Research Support Services Team consists of:
Nicole Humphreys – Clinical Trials Research Support Officer. Nicole has worked in the clinical trials space for more than 20 years with a Masters in Health Science (Clinical Trial Data Management) to support this experience. This position has been funded through a CTRSS Pilot Program with Department of Jobs, Precincts & Regions (DJPR). (Left above)
Jacqueline Lake – Clinical Trials Assistant (Intern) Jacqueline has recently completed a Bioscience degree and Honors at Deakin University and is now completing a 12 month internship and assisting with all aspects of clinical trial management at NHW. (Right above)
Research at NHW enables us to
A Clinical trial is a research study that prospectively assigns people or groups to one or more health-related interventions to evaluate the effects on health outcomes. (World Health Organisation) Clinical trials can be observational (cohort & case control studies) or experimental (randomised controlled trial) in design. A clinical trial does not always involve drug treatments. They can also be testing a medical device, a therapy or a technology.
The benefits of clinical trials are:
These organisations and websites provide introductory training and general resource around Clinical Trials:
AustralianClinicalTrials.gov.au is a joint initiative between the National Health and Medical Research Council and the Department of Industry, Innovation and Science to provide information and resources to consumers, health care providers, researchers and industry about clinical trials.
The resources on this site are designed to assist by providing information and guidance.to the growing Australian clinical trials sector who are developing or conducting a clinical trial as a principal or co-investigator or becoming affiliated with a clinical trials network.
PRAXIS Australia provides an array of educational services to the clinical trials, HREC and research sector in the form of both online and in-person training options.
Global Health Training Centre
Free eLearning courses in global health research for staff of all roles, in all regions and covering all disease areas, developed by The Global Health Network in collaboration with respected partners such as the World Health Organization
Datapharm Australia offers Introduction to Clinical Research training courses in 2021. These include both face-to-face and remote courses for those who would not readily be able to travel to attend.
The GRS Good Clinical Practice (GCP) Course is designed to prepare both investigators and research staff for the conduct of clinical trials with human participants. The intent of this training program is to define the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2).
Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.
The National Drug Abuse Treatment Clinical Trials Network's Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.
Victorian Clinical Trials Education Centre (V-CTEC) is a not-for-profit, Victoria wide, member-based education centre, with a dedicated Learning Management System (LMS) hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs. Free but registration is required.
A teletrial allows a clinician at a larger centre (primary site) to enrol, consent and treat patients on clinical trials in partnership with smaller regional and rural centres (satellite sites), allowing patients to participate closer to home. This group of sites operating under the teletrial model is called a teletrial cluster.
The VCCC teletrials model is a flexible approach to conducting trials, delivering a significant opportunity to overcome geographical barriers.
Investigator-initiated trials (IITs) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution. Most IITs are designed to support the development of new clinical practice guidelines or compare the effectiveness of existing treatments.
AustralianClinicalTrials.gov.au is a joint initiative between the National Health and Medical Research Council and the Department of Industry, Innovation and Science to provide information and resources to consumers, health care providers, researchers and industry about clinical trials.
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Guidance on conducting clinical trials in Australia using ‘unapproved’ therapeutic goods
The Australian Clinical Trial Handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation. Download pdf - 825.7 KB
Clinical Trials Sector ReportsClinical trials are a critical step in the research and development process for new drugs, vaccines, medical devices and diagnostics. Participants in clinical trials get early access to these potentially life-saving new therapies, while at the same time advancing medical knowledge. More broadly, clinical trial activity contributes to the development of a thriving research culture within Australia's healthcare system and promotes Australia's international research profile.
A global reputation for clinical trials excellence has made Australia a go-to destination for companies wanting to conduct clinical trials and seen the clinical trials sector develop into one of the country's most important and valuable services exports.
This report, Australia's Clinical Trials Sector: Advancing innovative healthcare and powering economic growth, developed through extensive and whole-of-sector stakeholder engagement, provides a snapshot of the size and scope of Australia's clinical trials sector. It examines how the sector is performing, highlights the significant contribution that the conduct of clinical trials makes to the Australian economy and better health outcomes, and identifies opportunities for future growth.
ARCS Australia Ltd is a national, membership-based organisation focused on the development and growth of the healthcare sector. ARCS provides education, career pathways, professional development and advocacy to the healthcare sector
VCCC alliance member staff, consumers and members of the cancer workforce can register for access to online learning resources from the Victorian Comprehensive Cancer Centre Learning Hub. A wide range of resources is available, including recently added short courses in effective communication, clinical trials and haematology and clinical trials.
The Commission has finalised the draft National Clinical Trials Governance Framework (Governance Framework) following national consultation. Development of the Governance Framework is underpinned by a literature review and mapping exercise of national regulation and legislation and jurisdictional legislation, polices and processes with which clinical trials must comply.
Principal Investigator: Dr Kay Xu
CAMBRIA-2 is a phase 3, open label, randomised study to assess the efficacy and safety of Camizestrant versus standard endocrine therapy as adjuvant treatment for patients with ER+/HER2- early breast cancer and an intermediate-high or high risk of recurrence, who have completed definitive locoregional treatment and have no evidence of disease. More...
Principal Investigator: Dr Jade Radnor
SNaPP is a feasibility and pilot study for a multi-centre, patient and observer-blinded randomised controlled trial of Sugammadex or neostigmine to reverse neuromuscular blockade in adult patients having abdominal and thoracic surgery under general anaesthesia. More . . .
Principal Investigator: Dr Jade Radnor
TRIGS is a multi-centre, pragmatic, double-blind, randomised clinical trial to compare the incicence of surgical site infection and red cell transfusion requirements after IV Tranexamic Acid and Placebo in patients undergoing gastrointestinal surgery. More...
Principal Investigator: Dr Robert Krones
Sub Investigator: Dr De Witt Oosthuizen
ETERNAL is a multi-centre, randomised, open label, blinded endpoint (PROBE), phase 3, parallel group, controlled trial using tenecteplase versus ‘best practice’ which may be Alteplase or standard care for patients with Acute Ischaemic Stroke with large vessel occlusion presenting to hospital within 24 hours of symptom onset. More ...
