Testing new treatments, drugs and devices

IHMRI’s well-equipped Clinical Research and Trials Unit (CRTU) offers facilities and services for a range of clinical research studies and commercial clinical trials. Our region’s stable and accessible population base, which is set to grow to over 465,172 by 2036 (Wollongong City, Shellharbour City and Shoalhaven City Councils), demographic and economic diversity, and incidence of chronic disease, makes it ideal for population health studies and clinical trials. Read more about our region. To see the range of equipment and services available visit Assistance with clinical trials. Members of the community who are interested in taking part in clinical trials can read more at Participate in clinical trials.

Current clinical trials

There are a number of Investigator Initiated clinical trials that are conducted in the CRTU, here is a summary of the current clinical trials:   The CRTU is home to the Australian Centre for Electromagnetic Bioeffects Research, led by Senior Professor Rodney Croft, which conducts a range of clinical trials. Current trials include:

  • Mobile Phone & Emotion Study – determining if exposure to a mobile phone affects brain electrical activity
  • Mobile Phone and Infra-red Exposure Study – testing the thermal hypotheses of RF-EMF effects on Brain Electrical Activity
  • Sleep Study – Determining the influence of circadian phase on the RF-EEG effect

A team of researchers from the UOW’s School of Medicine, Smart Food Centre, led by Professor Karen Charlton, have worked on a number of studies in the CRTU. Current trials are:

  • Queen Garnet Plum Juice: A randomised controlled trial evaluating the effects of fruit derived anthocyanins for mild cognitive impairment
  • SYMBIOTiC StudySYMptom, microBIOme and dieT in Chronic Kidney disease. A new renal diet designed to improve gut health, diet quality and other clinical outcomes for patients with chronic kidney disease now recruiting 
  • Vitamin D and Bone Health Study in Australian Women A landmark study looking at what determines vitamin D status in women by reviewing skin type latitude, diet, and sun exposure now recruiting

Dr Monique Francois from the UOW’s School of Medicine, Medical and Exercise Science and her research team have been working on the following clinical trial:

  • GDM Supper Study – a national study investigating whether consuming a snack 30 minutes prior to bed is a viable treatment option to improve fasting glucose levels in women with gestational diabetes mellitus (GDM) – now recruiting
  • Preventing cardiovascular disease in people with type 2 diabetes: When is the best time to move? This project seeks to determine the feasibility and effectiveness of timing exercise to control blood glucose levels and reduce cardiovascular risk in people with Type 2 Diabetes – now recruiting

Dr Susan Thomas from the UOW’s School of Medicine and her research team have been working on the following clinical trial:

  • Mood, Food and Biomarkers Study – this trial is looking at the correlation between hormone levels and the behaviours and symptoms of depression

Associate Dean Paul Stapley, UOW’s School of Medicine and his team are currently conducting the following studies in the Movement Lab:

  • Does Periodised eccentric cycle exercise translate to improvement in on-bike power output? This study aims to determine if eccentric (backwards) cycling exercise improves in on-bike power output in novice and elite cyclists
  • What impact does submaximal-intensity eccentric cycling have on the cortical and spinal pathways? This study aims to investigate if eccentric cycling improves neuromuscular and cognitive functions

Dr Winson Lee, UOW’s School of Mechanical, Materials, Mechantronics and Biomedical, and his team are currently approved to conduct the following study in the Movement Lab:

  • Wearable technology to improve movement performance – A pilot study in finding a better way to motivate elders to walk longer by giving personalized feedback verbally and using smart technology

Supported trials 

The CRTU staff also assist UOW Researchers with their clinical trials by offering their professional services. These Researchers include:

  • Dr Carolyn Dillon from the School of Chemistry, and her study Development of novel therapeutics for the treatment of cancer and inflammation
  • Dr John Sampson from the School of Medicine, and the study, Timely resolution: an analysis of lipid mediated inflammation following exercise induced muscle damage

Commercially sponsored trials

The CRTU also conduct commercially sponsored trials, current trials include:

  • ColoSTAT® study: A simple low cost blood test for the early detection of colorectal cancer.  Developed over 13 years of research by the CSIRO and now being trialled by Rhythm Biosciences.  This study is now open to recruitment.  If you are aged 40 < 85 and are having a colonoscopy in the next 3 months, you may be eligible to participate.  Principal Investigator for the study is Professor Phil Clingan. Now recruiting. 
  • Shingles Vaccine – Zoster 049 study. A long running trial involving 31,000 people in 18 countries.  Recruitment closed
  • Myovant SPIRIT EXTENSION study. An extension of the SPIRIT 2 study for women with Endometriosis-Associated Pain. Recruitment closed
  • DUPLEX – Renal Study. A randomised, multicentre, double blind, parallel, active control study of a new drug for patients with Primary focal Segmental Glomerulosclerosis (FSGS). Open for recruitment
  • CLEAR Cardiovascular Study. A study assessing the effects of a new drug on the occurrence of major cardiovascular events in patients who are statin intolerant. Recruitment closed

Past clinical trials

  • Asthma medication study—using existing medication in a new way to see if asthma management can be improved
  • Over Active Bladder (OAB)—testing safety and tolerability of a new combination of drugs to improve the symptoms of OAB.
  • COMPOSE—a clinical study to assess the safety and potential efficacy of a compound to improve memory, language and learning in people with Down Syndrome.
  • Obesity study—a placebo-controlled weight loss study of an investigational medication.
  • Osteoarthritis study—assessing the effectiveness of a new drug to relieve pain.
  • Gout study—an evaluation of an investigational drug to see whether, when combined with allopurinol, it reduces high uric acid levels in the blood.
  • Cold sores—testing an investigational mouth wash to reduce duration of cold sore episodes.
  • Shingles vaccine—a long-running trial involving 31,000 people in 18 countries (the vaccine was shown to be 97 per cent successful in protecting older people from shingles, as reported to the New England Journal of Medicine).
  • Myovant SPIRIT 2 Study. An International Phase 3 Randomised, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a new drug for women with Endometriosis-Associated Pain.

In the news

Contacts

Clinical Director

Professor Leonard Arnolda

T: +61 2 4221 4307 E: larnolda@uow.edu.au

C

Clinical Research Program Coordinator Julie Ferguson RN T: +61 2 4221 5951 E: fjulie@uow.edu.au

c

Senior Clinical Trials Coordinator Kim Bloomfield T: +61 2 4221 5517 E: bloomfie@uow.edu.au