Over $17m secured in clinical trials cohort studies grant scheme

Monash Medicine, Nursing and Health Sciences researchers have successfully secured $17,484,794 from the latest NHMRC Clinical Trials and Cohort Studies Grants.

The aim of the Clinical Trials and Cohort Studies grant scheme is to support high-quality clinical trials and cohort studies that address important gaps in knowledge that can be transformed into findings to improve human health, wellbeing and health care practice or policy.

The Faculty is leading in five research projects that have received funding, focusing on early detection of melanoma, insomnia during pregnancy and postpartum, exploring the effects of statins on cognition and much more.

Deputy Dean and Director of Research at Monash Medicine, Nursing and Health Sciences, Professor Ross Coppel said that the funding will greatly support our efforts in delivering high-quality and cost-effective clinical trials.

“With our four state-of-the-art clinical trials facilities across Melbourne, ISO-certified technology platforms and highly-skilled researchers, we are a world-class destination for clinical trials and cohort studies, tackling some of the most pressing medical issues. Congratulations to all of our researchers who have been awarded funding.”

Some of the projects that have received funding are:

Reconceiving early detection of melanoma $3,217,920.20 

Adjunct Associate Professor Victoria Mar will lead the Victorian wing of a project leveraging the $10million Australian Cancer Research Foundation funded Australian Centre of Excellence for Melanoma Imaging and Diagnosis (ACEMID) infrastructure, to standardise melanoma diagnosis, improve risk stratified surveillance strategies and patient outcomes.

Skin cancer treatment in Australia costs the healthcare system over $1 billion annually, and melanomas account for more than 2,000 deaths per year. Early detection improves prognosis, however, there is no clear standardised pathway to achieve this. Diagnostic accuracy between clinicians is variable, and high variability between pathologists in identifying benign nevi versus melanoma has also been recorded.

15,000 patients across Queensland, New South Wales and Victoria will receive cutting-edge 3D total body imaging as part of the trial.

Clinical trial to determine the effects of statins on cognition: STAREE-Mind $2,795,199.60

Associate Professor Joanne Ryan is leading this new sub-study that will investigate if cholesterol-lowering statins offer a safe, widely applicable, low cost strategy to preserve cognitive function among older Australians.

Observational studies have suggested that statins decrease risk of vascular dementia and Alzheimer’s disease, however no robust randomised clinical trial has studied these effects. Such robust evidence is urgently needed for both consumers and clinicians to make informed decisions about preventive statin use, and STAREE-Mind will fill this knowledge gap.

It leverages the STAtin therapy for Reducing Events in the Elderly (STAREE) RCT, investigating whether daily statin treatment reduces cardiovascular events and prolongs disability-free survival over five years in individuals aged ≥70 years. This critical funding will enable sensitive neurocognitive tests to be administered longitudinally and neuroimaging to be added to the parent trial.

Low OxyGen Intervention for Cardiac Arrest injury Limitation trial (LOGICAL) $2,314,402.60

Professor Carol Hodgson leads this definitive phase 3 trial that will evaluate the effect of usual (liberal) oxygen therapy versus conservative oxygen therapy on neurological outcome in critically ill patients who are mechanically ventilated following cardiac arrest.

14,000 participants will be recruited across Australian and New Zealand Intensive Care Units, and the study design has been directly informed by the team’s experience leading ICU-ROX, a trial that was recently published in the NEJM. Those results showed that in a sub-group of cardiac arrest patients, protective conservative oxygen therapy improved survival by an absolute difference of 13%, supported by an updated individual patient data meta-analysis of RCTs of protective conservative or liberal oxygen therapy after cardiac arrest.

If this trial demonstrates significantly improved functional outcomes from this strategy, the findings would rapidly change practice and deliver a profoundly important and impactful result for global health, given the hundreds of thousands of cardiac arrest patients receiving mechanical ventilation each year.

A Scalable Insomnia Program during the Pregnancy and Postpartum Periods: An Effectiveness-Implementation Hybrid Trial $877,335.40  

In Australia, approximately 300,000 women give birth each year, with 1 in 3 experiencing significant sleep disturbance and symptoms of insomnia.

Dr Bei Bei is leading the trial that aims to evaluate the effectiveness, cost-effectiveness, and implementation potential of a scalable Cognitive Behavioural Therapy (CBT) sleep program, which harnesses innovations in delivery to maximise impact, with the potential to achieve sustainable integration in routine perinatal care. Currently, using CBT for better sleep is largely inaccessible and not part of perinatal care.

The trial’s pilot data strongly suggests that CBT works well for women during both pregnancy and postpartum periods: in women with sleep complaints, CBT improved sleep quality and reduced daytime sleepiness/fatigue, with benefits extended from pregnancy all the way through two years postpartum.

The findings will have a significant impact as it will offer an effective non-pharmacological sleep program for new mothers, helps improve insomnia disease burden, and improves the overall health and wellbeing of women and families across Australia.

INTERCEPT (Investigating Novel Therapy to target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): a multi-arm, precision-based, recursive, platform trial $5,867,515.10 

Acute myeloid leukemia (AML) is a rare but lethal blood cancer capable of rapid, adaptive resistance. The current paradigm is that patients are usually re-treated when disease progression is at an advanced stage.

New technologies can now sensitively detect protein or molecular “fingerprints” of leukemia at the earliest stages of returning disease prior to clinical relapse.

Adjunct Associate Professor Andrew Wei is leading a world-first, precision-based trial aimed at extending the duration of patient response using novel combination options targeting AML at the earliest stages of disease progression. In essence, INTERCEPT aims to suppress and eradicate relapse before the patient becomes clinically unwell.

About Monash University

Monash University is Australia’s largest university with more than 80,000 students. In the 60 years since its foundation, it has developed a reputation for world-leading high-impact research, quality teaching, and inspiring innovation.

With four campuses in Australia and a presence in Malaysia, China, India, Indonesia and Italy, it is one of the most internationalised Australian universities.

As a leading international medical research university with the largest medical faculty in Australia and integration with leading Australian teaching hospitals, we consistently rank in the top 50 universities worldwide for clinical, pre-clinical and health sciences.

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