CCReW Clinical Trial/Research News 8Nov22

Dear

Sometimes things don't quite go to plan. Today I was supposed to be at the Australian Clinical Trials Alliance (ACTA) Annual Scientific Meeting (ASM) in Adelaide. But alas, an awkward twist on the weekend rendered me unable to travel and meet up with all the Adelaide local and inbound consumers, and our CCReW scholarship holders. I do hope everyone has a great time and I look forward to hearing about your experiences.

Over the past couple of weeks there's been lots of webinars and activity supporting the movement for greater consumer involvement in research. For example, the Medical Research Future Fund's assessment criteria descriptors to include more explicit expectations for consumer involvement. The Australian Academy of Health and Medical Sciences released a vision statement for integrating research into healthcare which identified consumer and community involvement in research as a key pillar. The MRFF priorities for 2022-24 went live yesterday, with consumer-led research remaining a key priority with a nice rewording about the need to build connections between consumers and researchers.

The Health Translations SA October webinar series exploring consumer involvement in research was a highlight, as were webinars by Monash Partners/Sydney Health partners, and HealthConsumers NSW/Sydney Health Partners. I'd highly recommend catching up on the recordings of all these events.

Next Tuesday, the NHMRC & CHF are launching a consultation to revise the current Statement on Consumer Involvement in Health and Medical Research into a principles-based document. The link to register for the workshop launch is in the events section below. I am one of a few speakers sharing our thoughts, and I'd really like to encourage as many consumers as possible come along to share their perspectives too.

I'd also encourage you to take a look a the WHO consultations listed below that close this Friday 11 Nov, as they are important for improving transparency, accessibility, safety and quality in clinical trials globally. Its a busy time!

Until next time, may the world be kind to you.

Janelle.

AccessCR and the CCReW initiative

This is a list of all studies on the ANZCTR approved by a human research ethics committee, recruiting in Australia, with a trial start date between 25Oct-7Nov2022 not previously listed here, as at 7Nov2022.

Comparative Bioavailability of Smartech 2% Sodium Diclofenac Topical Solution and PENNSAID 2% Applied to the Knees of Healthy Male and Female Subjects. This randomised, open-label, multiple-dose, 2-period crossover Phase 1 study running in Adelaide is looking for up to 32 medically healthy people aged 18-55 years.
The effect of pump speed and a vessel dilating medication on the exercise capacity of patients with left ventricular assist devices (artificial heart pumps). This interventional, randomised controlled, open label, crossover trial running in Sydney is looking for 16 people aged 18 or older that are more than 2 months since artificial heart pump insertion.
Benefits of Analysing Brain Biomarkers in perinatal care: a prospective observational cohort study. This observational cohort study is aiming to collect 3mL of cord blood the placenta of 110 women giving birth at a centre in Sydney.
Effectiveness of neutraceutical therapies on symptoms in adults with long-COVID-19: The Alliance Long COVID-19 Treatment Trial. This interventional treatment trial running in ACT, NSW, QLD, SA and VIC is looking for 60 people aged 20 years and older who have had COVID19 more than 3 months ago and persistent symptoms longer than 3 months.
SGLT2 Inhibition with Empagliflozin on Metabolic, Cardiac and Renal Outcomes in Recent Cardiac Transplant Recipients. This randomised controlled, blinded, Phase 2/3 treatment trial running in Sydney is looking for 100 cardiac transplant recipients within 6-8 weeks of transplant aged 18 years and older.
Neuromodulation using scanning ultrasound in Alzheimer’s disease. This open-label, non-randomised safety trial running in Brisbane is looking for 12 people with biomarker confirmed Alzheimer’s disease aged 50-85 with an MMSE equal to or greater than 10 and a regular carer who can attend appointments and provide information about adverse events.
Effect of pre-sleep alpha-lactalbumin supplementation in a trained population with sleep difficulties. This randomised-controlled, double-blind, phase 4 crossover trial is looking for 18 people aged 18-40 years whom complete moderate-vigorous exercise at least 3x/week (min 5hr total/week) with at least mild sleep difficulty and poor-quality sleep. The 3 day intervention period will be completed onsite at Deakin University, VIC.
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight. This randomised-controlled, blinded phase 3 international. treatment trial is looking for people aged 18 or older with a BMI of at least 30 kg/m2 or 27 kg/m2 with at least one weight-related comorbidity is looking for 3400 people globally. There are research sites in NSW and QLD.
The GORE® VIAFORT Vascular Stent IVC Study. This non-randomized, single-arm medical device study running in Adelaide and Perth (and NZ) is looking for 111 people aged 18 years or older meeting the criteria for the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction.
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer. This randomised-controlled, open label Phase 3 international study running in Perth is looking for 320 people globally with locally advanced, unresectable Stage III Non-Small Cell Lung Cancer of either squamous or non-squamous histology with specific treatment history.

A researcher asked us to share this trial currently recruiting:

VRWalk – Virtual Walking for Treatment of Neuropathic Pain following Spinal Cord Injury. Researchers from UNSW/NeuRA are looking to recruit 62 people with a complete spinal cord who have chronic neuropathic pain to see whether we can use virtual reality walking to help reduce the pain. The intervention is done at home so we are recruiting Australia wide. For more information: VRWalk Trial | NeuroRecovery (neurorecoveryresearch.com) or https://clinicaltrials.gov/ct2/show/NCT05005026

This listing is a free service to help people know what studies have recently started that they or someone they know could have an interest in. Please contact researchers directly through the listings as we have no connection/involvement with these studies. If you do contact a researcher, or enter a trial on the list, please let us know. We would love to know whether these listings are helping people find studies.

If you are a researcher that wants to let people know about your recruiting trial here, please contact us (first listing free, subsequent listings for a fee).

The following are some upcoming activities we/ve spotted that may be of interest:

Victorian Comprehensive Cancer Centre EOI: Personalised Cancer Care Consumer Reference Group. Help provide advice based on your experience around the value of integrating molecular tests such as genomics into routine cancer care. Applications close 5.00pm, Tuesday 8 November 2022.
WHO Open consultation: WHO ICTRP guidance for reporting summary results in clinical trial registries. There is substantial variation in the elements of summary results collected by trial registries. To promote harmonisation, recommendations for the minimum elements of study results that should be reported in trial registries has been drafted. The purpose of this consultation is to solicit feedback from stakeholders - including researchers, patients, journal editors, funders, industry sponsors, and regulators - on key components of this draft guidance. The deadline for submitting feedback is 11 November 2022.
WHO Open consultation: WHA 75.8: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. The deadline for submitting feedback is 11 November 2022.
The National and Health and Medical Research Council (NHMRC) and the Consumers Health Forum of Australia (CHF) are convening a stakeholder consultation workshop to begin the review process of the NHMRC and CHF Statement on Consumer and Community Involvement in Health and Medical Research. The workshop will be held on the 15th November 2023 , 1-4pm (AEST) via MS Teams. Register now through Eventbrite.
Health Consumers NSW Showcase ‘Celebrate Connections: Designing the future together’.
is being held in Sydney Fri 18 Nov, 10am-2pm.. Register online.
Monash Partners is holding a free webinar 22 Nov 22, 10am where a panel of clinicians, researchers, health service leaders, researchers and consumer representatives will answer your questions on the successes and challenges of integrating community and consumer involvement into practice. Register online.
The NHMRC Research Translation Long Weekend 2022 is a hybrid event, combining in-person events with online events. Thursday 17 November to Tuesday 22 November 2022 (with a weekend break). Sessions will start at 12:00 AEDT (09.00 Perth, 14:00 Auckland) and end by 16:00 AEDT pm each day. Registration is free, but spaces are limited so don't delay.
Monash Partners webinar - Learning Health Systems – The why, what, who and how to improve care delivery and quality by 2030. 8Dec 1-2.30pm.

If you'd like to proactively advertise a consumer research involvement opportunity or event, then please get in touch for more information.