CCReW Clinical Trial/Research News 2Mar23

Dear

Thanks for you patience in waiting for this weeks newsletter. It's late due to one of those quirks of a service provider changing their systems with unintended consequences for their clients. If you are now receiving this, that's thankfully been sorted.

I know many of our community identify as people living with or supporting those living with a rare disease. In celebration of this week's Rare Disease Day, I'd like to wish you well in your efforts to advocate for recognition, research and support of the rare disease communities you are part of. We know now that rare is not rare - rare is many. And as we learn more about the genetics behind even the most pervasive health conditions, I truly believe we will all be rare one day. So I take my hat off to the rare disease communities that are innovating and paving the way for how research and trials many need to change in the future to deliver the evidence for what personalised medicine and care will benefit future patients.

A quick reminder to conference organisers that Belberry's newest round of participant engagement grants remains open for applications until 10 March 2023. Please think about how consumers could be integrated as speakers and attendees, enriching the experience for consumers, but also for the professional attendees that need opportunities to engage with and listen to consumer voices.

As always, there are lots of interesting opportunities and resources you might like to check out below. I'd particularly like to draw your attention the the ConViCTion work listed in the Stories section. And until we meet again, wishing the world is 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 30Jan - 14Feb23 not previously listed here, as at 14Feb23.

Feasibility of push notifications in the management of heart failure: a randomised pilot trial (NOTIFY-HF). This open label, randomised controlled, prevention trial running in Liverpool, NSW is looking for 200 people aged 18 years or older with Heart Failure, and a compatible Boston Scientific Cardiac Implantable Electronic Device (CIED) capable of heart failure diagnostics (HeartLogic) and remote monitoring implanted 45 days ago.
The effects of glucagon-like peptide-1 on glycaemia in the critically ill. This blinded, randomised controlled, phase 2 treatment trial running in Adelaide is looking for 40 critically ill people aged 18-80 years admitted to the Royal Adelaide Hospital Intensive Care Unit, mechanically ventilated and about to start intravenous insulin.
Enhancing the clinical effectiveness of deep TMS treatment of depression. This randomised controlled, blinded treatment trial running in NSW,QLD,and VIC is looking for 240 people aged 18-85 years with diagnosis of major depressive episode in the context of unipolar major depressive disorder or bipolar affective disorder, and treatment resistant depression.
Assessment of Magnesium administration effect on Atrial Fibrillation duration in patients admitted to the Intensive Care Unit. This non-randomised controlled, open label, phase 4 treatment trial running in Melbourne and Ballarat VIC is looking for 300 patients aged 18years or older admitted to intensive care who are invasively mechanically ventilated and receiving vasoactive agents.
'One injection vs. three': Clinical evaluation of a single, high dose subcutaneous infusion of benzathine penicillin G for treatment of syphilis (SCIP Syphilis). This non-randomised, phase 2 trial running in Fremantle, WA is looking for 40 males and non-pregnant females aged older than 18 years diagnosed with syphilis and requiring treatment with benzathine penicillin G in the form of Bicillin® L-A.
Pharmacy-Based Screening and Quality Use of Medicines in Kidney Disease. This open label, randomised controlled, diagnostic trial running in NSW, QLD and VIC is looking for 3660 participants. To be eligible for screening, participants must be aged between 35-74 years, have at least one risk factor for chronic kidney disease and not have kidney failure or not be receiving kidney replacement therapy.
Efficacy of Fucoidan for eosinophilic oesophagitis: a phase 2 pilot study. This randomised controlled, blinded phase 2 trial running in the Gold Coast, QLD is looking for 36 people aged 18-60 years diagnosed from biopsy with eosinophilic oesophagitis and prescribed treatment with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks.
A comparison of lignocaine plasma levels and efficacy of two preparations of 2% lignocaine for airway topicalisation in healthy physician volunteers. This randomised controlled, blinded phase 3/4 trial running in Gosford NSW is looking for 42 healthy physician volunteers aged 18-65years who are prepared to attend the awake fibreoptic intubation course.
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months. This randomised controlled, blinded Phase 1 trial running in QLD, SA, VIC and WA is looking for 210 participants in good health aged 8 months to <24 months (Part A) or 5 months to <8 months (Part B).
Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes. This randomised controlled, blinded phase 2 trial running in NSW, QLD, SA, VIC, and WA is looking for 62 people aged 6 - 21 years weighing at least 20kg diagnosed with Diabetes mellitus within 100 days of visit 2.
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008). This randomised controlled, blinded phase 3 prevention trial running in Sydney and Brisbane is looking for 500 people aged 18-64 years, on stable treatment for one of a range of conditions (eg diabetes mellitus, COPD, asthma, chronic heart disease etc) at risk for pneumococcal disease.
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors. This first-in-human, open-label, phase 1 trial running in VIC and SA is looking for 21 people aged 18years or older with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists. A number of other criteria apply.
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours. This open-label, non-randomised, phase 1 trial running in Adelaide is looking for 40 people aged 18-85 years with advanced colorectal, gastric/gastroesophageal adenocarcinoma, or ovarian cancer that has progressed or is not suitable for standard of care systemic therapies. A number of other criteria apply.

Please contact researchers directly through the listings as we have no connection/involvement with these studies. If you do contact a researcher or join one of these trials please drop us a note so I know whether providing this listing is useful and helping people find trials.

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

Over the past 12-18months, I've been involved with a project team supporting a consumer advisory group for clinical trials in NSW called ConVICTioN. They were tasked with coming up with something that might improve clinical trial awareness and participation in NSW. After much discovery research, they found many of the materials available share the benefits researchers believe clinical trials have, rather than the benefits consumers experience from participating.

ConViCTioN set about producing some materials that were strictly consumer led and delivered messages. These materials have been recently launched for anyone to use. Here's a blog post I've written that shares my experience of working with this group, with links to the resources they have developed. I encourage you to take a look at the resources, and importantly, use them to help raise awareness of clinical trials and encourage people to look into them further.

We are always looking for stories to share on our blog and socials from trial participants, consumers involved in research or the carers and family that help support people do either, or researcher involving consumers in their work. If you'd like to share yours, please get in touch. And, feel free to catch up with stories already shared on our blog or Facebook Page.

The following are some upcoming opportunities and events spotted that may be of interest:

Expressions of interest are now open to join the Primary Care Collaborative Cancer Clinical Trials Group (PC4) Community Advisory Group (CAG). This CAG provides advice on research directions and priorities from a consumer perspective. To join this CAG you may have had cancer, known or cared for someone with cancer, or just be interested in cancer research and in helping people. This is a volunteer position and experience in research is not required. Learn more and apply on their website. Expressions of interest close on 3Mar23.
VCCC Alliance Biostatistics Online Workshop 9Mar23. Learn how to interpret the reporting of statistical results in clinical studies. Designed for the non-statistician.
Learn about Medical Research Future Fund (MRFF) grant assessment processes at the next MRFF webinar - 15Mar23, 2pm (AEDT). (Watch previious MRFF webinars here)
The Pharmaceutical Society of Australia invites all pharmacists and consumers to provide feedback on the revised draft of the Professional Practice Standards (PPS). Submissions close 17Mar23
Australia’s National Science and Research Priorities and National Science Statement will provide direction for our science system. The Govt are seeking your views on refreshing the priorities to reflect Australia’s ambitions and challenges. Submissions close 31Mar23.
ARCS are inviting applications from consumers interested in free registration to their annual conference, 6-8Jun in Sydney. Learn more and apply here. Deadline for applications: 14Apr23
The National Health and Medical Research Council's (NHMRC) is seeking consumer and community representative peer reviewers for the Targeted Calls for Research (TCR) scheme. New measures have been introduced to allow consumers and community representatives to score research applications received through NHMRC’s TCR scheme.
Patient Focussed Medicines Development (PFMD) is soon launching the Fair Patient Engagement Planner, a co-created tool to empower transparent dialogue on fair remuneration and drive good practice. They are looking for testers for the tool from patients communities and various pharma functions. Contact Nicole Wicki for more information.

If you'd like to proactively advertise a consumer research involvement opportunity or event, or would like to engage our help or advice on an activity, then please contact AccessCR.

Here's a few resources (old and new) you might be interested in:

Cancer Institute NSW: New multi-lingual resources connecting communities to cancer clinical trials
Patients as Partners in Clinical Research has been sharing interview stories over the past few weeks with individuals representing six underrepresented patient communities on their barriers to accessing clinical trials - including the LGBTQ+, sickle cell disease, autism/ADHD, latino and hispanic commjunities and more. They are US-based, but insightful and worth a look.
The Co-Production Colllective UK: a community of people interested in coproduction. includes resources.
Couch Health Report: The power of patient engagement in medtech
UK Research and Innovation: Taking public involvement into the research lab.
EUPATI Toolbox - a series of resources to support medicines research & development and patient engagement.
AccessCR's clinical trials jargon buster and Knowledge page for information and support around clinical trials basics, asking your doctor about trials, helping clinicians with information on trials and more. Check out our latest webpage sharing resources for involving consumers in research.