CCReW Research News 31Oct24

I couldn't quite squeeze in the Brisbane CCReW meetup on the 7Nov, but let's do it early 2025. You might also see me in sessions at the National HREC conference, Australian Clinical Trials Alliance (ACTA) conference, ARCS Melbourne Summit and MTP Sector Gala Dinner , plus a few other events and activities over the next month. So do say hi if we cross paths.

CCReW members Penelope McMillan and Brian Beh are madly preparing to present the abstract some of the CCReW co-created for the National HREC conference - entitled Lived experience and the HREC review process – opportunities. I do hope you will engage with and support them in the Practical Strategies 2 session the afternoon of the 27th Nov, as well as Geoff Cadzow, in the panel session I'll also be in on the 28th Nov.

The PxP conference sessions are now available on YouTube to view. Though the last 'You Can't Ask That Session' was not recorded, a graphic artist captured the content of the discussions. You can see just how many topics we got through in an hour, and quite frankly, it summarises many of the challenges that exist in this space.

Congratulations to the latest CCReW Travel Scholarship recipients - Saran Chamberlain and Michael Elwan. Saran has an interest as a consumer in stroke, and will be travelling from Adelaide to attend the ACTA conference in Melbourne. Michael has a consumer interest in mental health, and will be travelling from Perth to attend the Manna Institute symposium in Sydney.

I am still working on pulling people together to help with a conference next May to celebrate excellence in participant experience and consumer partnership in research. I'll be needing help from lots of people if I am to keep it free for everyone to attend, including the Steering Committee, help with the Program/Awards and IT/communications, judges and sponsors. So if you are interested, please do reach out. (And I will be soon in touch with those that have already expressed interest, I promise).

On an interesting 'international policy' note, there has been an update to the World Medical Association's Declaration of Helsinki. For those unfamiliar with this document, it is a foundational document setting out ethical principles in human research, that turns 60 this year. What's new in the version released last week is it references the need for consumer involvement in research, along with greater inclusion of underrepresented populations in research. So the world is changing and the call to action becoming louder. For some commentary on the update, these articles may be of interest: JAMA editorial .

Today ends our second annual October Origami 4 Clinical Trials (O4CT) campaign where we encouraged people to Thank a Trial Participant. Though the campaign has concluded, we'd like to encourage those who know, support or recruit trial participants to make this something they do regularly. Clinical trials can only generate the evidence about what works and is safe, if trial participants exist. And 2365 days a year you can still request a trial participant to be gifted a sunflower from us, or a trial site to be sent sunflowers to gift (pending supplies). Else, you can always purchase sunflowers (made or kit form) from the CCReW shop as one way to say thankyou for their efforts, which also contributes to funding our efforts to support CCReW. Win-win!

The following is a list of trials from ANZCTR listed as having started recruitment between 30Sep-31Oct 2024 (as at 31Oct). For more details, click on the links to access the specific trial information.

Cancer

Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide, NSW.
IMProving the quality of life for rAdiation therapy prostate Cancer patienTs (IMPACT), NSW. AMLM26/T1 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - Gilteritinib+ Venetoclax, NSW, QLD, SA, WA, VIC.
AMLM26/T3 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - Low-dose cytarabine (LDAC) + Venetoclax, NSW, QLD, SA, WA, VIC.
Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for cancer: The ReDO cancer treatment study, QLD.
Phase II single arm study to explore the efficacy of cetuximab (in combination with irinotecan based treatment) in advanced stage RAS/BRAF wild-type right-sided colorectal cancer with high AREG/EREG expression, NSW, QLD, TAS, WA, VIC.
A phase 2 study investigating the impact of adding olaparib, or olaparib and durvalumab together, to standard chemotherapy before surgery in young, pre-menopausal women with HER2-negative breast cancer, NSW, QLD, WA, VIC.
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors, VIC.
A Phase 1a/b Study of BG-C477 in Participants With Advanced Solid Tumors, NSW, SA, VIC.
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49%, NSW, QLD, SA, VIC, WA.
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1), VIC.
Phase 1 study evaluating the Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment, NSW, VIC.
A phase 1 Study With [225Ac]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC), WA.
A Phase 1 Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors, VIC.

Respiratory

INFINITE: A Phase III Randomised Crossover Trial of Domiciliary Nasal High Flow for Chronic Breathlessness in People with Interstitial Lung Disease, VIC.
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders, VIC.
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis, SA, NSW, VIC.

Heart Related

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study), NSW, QLD, TAS.
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11), no location identified.

Musculoskeletal

Genicular Artery Embolisation (GAE) in Mild to Moderate Osteoarthritis: Correlation between Treatment Effect and Biochemical Biomarkers. This project is a sub-study of the PRAETORIAN registry, QLD.
Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA), VIC.

Neurological

First in Human Study of the Safety and Feasibility of Middle Meningeal Artery (MMA) Embolisation with the Arsenal Medical NeoCast Embolic System for the Treatment of Chronic Subdural Hematoma (cSDH), VIC, QLD.

Gastrointestinal

Evaluation of Body Surface Gastric Mapping in a Multidisciplinary Integrated Care Pathway for Chronic Gastrointestinal Symptoms, QLD.

Intensive Care

A pilot single-centre double-blind randomised controlled trial of the effect of centhaquine on stroke volume in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit, VIC.

Paediatric

Clinical outcomes following prescription of Vosoritide in children with Achondroplasia 0-2 years of age (observational study), VIC.

Healthy volunteers

An Open-Label Phase 1 Study to Evaluate the Systemic Pharmacokinetics and Bioavailability of RECCE®327 Topical Gel Applied to Normal Intact Skin in Healthy Male and Female Participants, NSW.
Phase I Study to Evaluate rhTPO in Healthy Caucasian Volunteers, VIC.
A Phase 1 Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years, VIC.

Other

IDEAL Care: Identifying Advanced Liver Fibrosis in Primary Care. WA, VIC.
ASCEND: a Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs, VIC.
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2), NSW, QLD, WA, VIC.
An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis, QLD, WA.

Researcher Requested listings (free):

1. FOCUSau is a digital platform that promotes wellbeing and quality of life whilst offering coping strategies, future planning advice and symptom management for people living with advanced cancer. It is currently in trial phase before an intended national rollout. The trial aims to recruit 500 people from across Australia, consisting of the person living with cancer and their primary family carer, to provide feedback on whether the program is effective before it is launched nationally. For more information about the FOCUSau study, please visit the website: https://medicine.unimelb.edu.au/focusau.
You can also call 03 9035 4153 or send an email to focusau-trial@unimelb.edu.au and a member of the research team will get in touch with you.

2. A team of researchers at the Australian National University (ANU) has initiated a research project to examine best practices for consumer representation in palliative care. This study aims to develop a framework for optimal role delineation and training for consumer leadership within palliative care. All experts currently working or who have worked in palliative care in Australia are invited to participate in this Delphi study. Targeted participants include, but are not limited to Healthcare practitioners; Patient representatives; Carer representatives; Researchers; Educators and Managers and board members of palliative care organisations. For more information, visit the study website.

Note we have no connection/involvement with any of the above studies. Please click the study link and scroll to the contacts section for whom to reach out to for more inormation. If the trial is not running near you, ask the researchers if there are other options or travel support available. We'd love to know if you make enquiries and join one of these studies. And if you have difficulty reaching the research team, please let us know that too.

If you are a sponsor or researcher that wants to let people know about your newly opened study, please complete our request form or contact us (it's free to list a trial once).

See below for opportunities and events we've spotted which may be of interest to CCReW:

See all the CCReW related events listed in the introduction.
A-CTEC November webinar: Improving Aboriginal and Torres Strait Islander people’s access to cancer clinical trials in regional Victoria. 7 Nov, 12.30pm to 1.30pm AEDT online
The MRFF’s $500.1 million Genomics Health Futures Mission supports genomic research to improve the testing and diagnosis of diseases, help personalise treatment options and reduce unnecessary interventions and costs. The Genomics Health Futures Mission Expert Advisory Panel (EAP) is reviewing the Mission’s vision, goals and priorities for investment by refreshing the Misson’s Roadmap and Implementation Plan (first published in October 2021). The MRFF invite you to contribute to this refresh by completing an online survey on our consultation hub by 8 November 2024. There is a webinar about this on the 4 Nov (see the consultation hub).
The National Medicines Symposium, 19 Nov, will bring together experts and practitioners to discuss innovative strategies for enhancing medication safety, reducing polypharmacy, and improving the quality of life for all Australians. Register online.
National HREC Conference 27-29Nov (Online and free). Register online.
Webinar: WHO launches new clinical trials guidance – What do I need to know? 13 Dec, 14:00 CET

Do you have an event or opportunity for consumers related to research you'd like to share in our newsletter? Please complete our request form or contact us. It's generally free to list unless it involves alot of time on our part to sort out.

Here's a few other bits and pieces you might like to engage with:

Check out the ‘Audit for Consumer Engagement (ACE) Tool’ from the AIHI at Macquarie University, Sydney. It can be used by healthcare staff, consumers or consumer representatives to assist in identifying the extent of and the opportunities for consumer engagement generated in the healthcare environment.
Take a peak at who was appointed to the new NHMRC-MRFF Interim Consumer Advisory Network that will advise the Chief Executive Officers of the Health and Medical Research Office and NHMRC on strategies for strengthening consumer involvement.
The NHMRC has published the report and recommendations from an NHMRC-organised workshop that brought together experts to discuss the opportunities and risks from the use of artificial intelligence in NHMRC and HMRO-funded health and medical research, and translation of this research.
Monash University have launched an online consumer engagement platform, open to all researchers from universities and companies across Australia who wish to engage consumers and community members in their research. Consumers can also sign up to contribute to research. With 1 project (to name the platform) showing, it is clearly early days.
The OurDNA program, led by the Centre for Population Genomics – a joint initiative of the Garvan Institute of Medical Research and the Murdoch Children’s Research Institute in Melbourne – will establish the first Australian large-scale genomics resource to address the critical gap in genetic research representation for Australia’s multicultural population.
Review the findings of Research Australia’s 2024 Public Opinion Poll on Health & Medical Research & Innovation.
Australian Research Data Commons (ARDC) have released resources to support clinical trials data sharing and reuse. It includes videos, guides and other tools.
Review the MRCT’s Accessibility by Design (AbD) in Clinical Research Toolkit - a comprehensive resource for all stakeholders to support greater inclusion of people with disabilities in clinical research.
The MRCT Center has released an introductory 12min video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies to provide an overview of the general principles in clinical research and quality by design. View it here.
A new course from MRCT - “Ethics and Review of Interventional Clinical Research,” is now available online free to anyone worldwide at OpenWHO.org. This course was developed to meet the growing demand for training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review interventional clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials.
Watch this webinar recording discussing one team's experience of developing plain language trial result summaries for participants in breast cancer relate studies.
Settle into a comfy space for some light(ish) reading:

Health consumer involvement boosts tube-feeding research. HTQ, Oct24.
FDA’s Tarver says clinical trial diversity action plans are a marketing opportunity. Reg Focus Oct24
Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023. JNCI Cancer Spectrum, Oct24.
Structural racism and inequity in cancer clinical trial participation: time for solutions. JNCI Cancer Spectrum, Oct24.
Patient engagement in drug development: dialogically problematizing participation. Science as Culture Aug 2024.
Credit where it’s due: Recognising lived experience in research authorship. Patient Ed & Counseling, Jan 2025.
It’s personal: navigating research questions that stem from our lived experiences. Intl J Epidemiol Dec 24.
The patients'/parents' voice within pediatric drug research. Academic Press, Jul 2024.
Patient centricity that delivers the ‘triple win’ is a business essential for pharma. PharmaTimes, 2021.
How can the value of patient engagement be quantified and measured? Pharmaphorum Nov23.
Developing a measure of participant experience of trials: qualitative study and cognitive testing. F1000research , Jan 2024.
Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age. CT Transp & Disclosure Sep 24.
The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial. Trials Journal.

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