CCReW Research News 6Dec24

We had 7 at our CCReW dinner meetup in Melbourne on Tuesday, 3 Dec. Despite the difference in people's locations and health interests, it never ceases to amaze me how common the issues are. That's why we are so committed to cross-therapeutic area sharing and networking to improve capacity and confidence.

It was lovely to meet our CCReW scholarship winner Saran (front right) in person, and I look forward to catching up with our other CCReW scholarship holder Michael to hear about his Sydney conference experience on Saturday.

November/early December has been busy with visits to Canberra, the National HREC conference, the ACTA clinical trials annual scientific meeting and ARCS Summit Dinner. What struck me about all these events was the very different cultures across these spaces, as well as how differently the lived experience is being talked about, incorporated and valued in the different stakeholder forums, from the complete embrace of patient voice, to discussions of why in one forum, to the how in another, to the almost complete absence of a mention or involvement in another. I will let you ponder which event did which, and in which stakeholder group there might be the most culture change required to achieve meaningful partnership! Of course, there are pockets of excellence in every group, and that comment doesn't seek to minimise the progress that has been made. But, there's always more to do, and as I said to one colleague I met yesterday, I will always 'poke the bear' to encourage more consumer involvement.

Congratulations to the many members of our Facebook group for their involvement in all these events. Watch Penelope and Brian's 12min recorded presentation at the HREC conference on opportunities for HRECs to consider the lived experience or check it out via the full HREC conference session recordings. If you didn't attend, I highly recommend reviewing the recordings for their insights and practical suggestions, especially with reference to the value of the lived experience.

A new National Health and Medical Research Strategy is being developed. A webinar was held yesterday (I was in a plane so am eagerly waiting the recording). However a survey was released at the end of the webinar to capture reactions on the development of the strategy. Visit this webpage for the link. I will keep the Facebook group updated as I hear more, and of course, provide updates through this newsletter.

CT:IQ are seeking feedback on a draft paper for human research ethics committees to guide HRECs around ongoing communication post consent with trial participants and their support networks, and what might/might not need approval by the 1 Feb. Complete the survey here to geive your feedback on what has been proposed.

Planning is underway for what will be a flagship event for us next year to celebrate the best in consumer partnership in research in Australia and I will have more to say on this shortly.

The following is a list of trials from ANZCTR listed as having started recruitment between 28Oct-30Nov 2024 (as at 30Nov). 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 (WOMBAT). NSW.
A phase 1/2 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.
A phase 1/2 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.
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.
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation. NSW, VIC.
A Phase I/IIa, First-in-Human Study Evaluating HX044 in Patients With Advanced Solid Tumor Malignancies. NSW, VIC, QLD.
An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1). NSW, SA, WA.
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma. NSW.
A Phase 1, Open-label Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation. NSW, VIC, WA.
A Phase 1, Open-label A Study of ZW191 in Participants With Solid Tumors. WA. A Phase 2, Open-label Study of AZD0486 as Monotherapy in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B). VIC, NSW, WA.
A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumorsv. NSW, SA.

Diabetes

A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both. ACT, NSW, QLD.

Respiratory

A Phase 2 Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. NSW, SA, VIC.
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial). NSW, QLD, SA, VIC, WA

Heart Related

The DECIDE study aims to test if dexmedetomidine can reduce delirium after surgery in patients undergoing cardiac surgery aged 65 years or older. NSW, VIC, QLD, SA, WA

Eye Related

A Phase 1a Open-Label Study to Evaluate the Safety and Tolerability of Intravitreally Administered PYC-001 in Participants With Confirmed OPA1 Mutation-Associated Autosomal Dominant Optic Atrophy. NSW.

Ear Related

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults with Severe Hearing Loss. VIC.

Musculoskeletal

Home strengthening exercise for knee osteoarthritis: the MULTI-ONE randomised controlled trial. ACT, NSW, NT, QLD, SA, TAS, WA, VIC.
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries. VIC.

Neurological

A Phase 2/3 Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation. NSW, VIC.

Pregnancy/Infant/Paediatric/Adolescent

The Canberra Family Study: Engaging with new parents to drive improvements in maternity service quality and family healthcare outcomes. ACT.
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Childrenv Trial (ID-MAGIC). NSW, QLD, VIC, WA.
Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2). VIC.

Healthy volunteers

Early phase study to assess the pharmacokinetics (how the body processes a drug), safety, and tolerability of ILYX-002 administered as an eye drop. SA.
Evaluation of interstitial fluid (ISF) Collection Methods and Metabolite Profiles in Healthy Humans. VIC.
A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-645 in Healthy Volunteers. QLD.
An On-track Trial to Assess Driving Risk, Impairment and Performance from Alcohol in Healthy Volunteers (This study is a sub-arm (Arm 2) of a larger study examining the effects of medical cannabis on real-world driving performance.) VIC
Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets. VIC.

Other

A smartphone and wearable tool to manage anger after trauma (Shift): A micro-randomized trial. ACT, NSW, NT, QLD, SA, TAS, WA, VIC.
A Closed-Circuit Track Trial to Assess Risk, Impairment and Performance from Medical Cannabis Among Patients. VIC.
Effectiveness of educational interventions to improve the quality use of medicines in Australian general practice for people with gout and older adults prescribed antidepressants. NSW, VIC.
Evaluating a co-designed shared care model of care on the quality of life of patients accessing gender affirming hormone therapy. VIC.
A Phase I First-in-Human study to assess EBC-1013 Gel in participants with venous leg ulcers. QLD, VIC.
A Phase 3 Study to Evaluate TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU). NSW, VIC, WA.
A Pilot, Safety and Clinical Activity, Phase 1b Study of DR-01 in Adults With Alopecia Areata or Vitiligo. NSW, QLD, VIC, WA.
Eating Disorder Genetics Initiative 2 (EDGI2) (enrolling participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls). QLD.

Researcher Requested listings (free):

The ACCELERATE Peanut trial is a phase 1, randomised, double-blind study to evaluate a novel injectable, allergen-specific antibodies that targets peanut protein. Currently recruiting 15-55 years old individuals diagnosed with peanut allergy at 4 sites in Australia.

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:

NSW Regional Cancer Research Network are offering 4 Consumer Conference Travel Grants to its members to attend the COSA Survivorship conference. Be quick as funding is allocated in order of application.
ARCS Conference Abstracts deadline has eben extended to 8 Dec. (There's no word yet on consumer scholarships or speaker travel reimbursement, so consumers submitting an abstract should make sure they have a backup plan for getting travel costs covered in case ARCS don't cover these).
The VCCC are hosting an in-person and online Consumer Engagement Forum, 9Dec, 10am-12pm. (There seems to be a waitlist for online at the moment).
The MRCT Center, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures, and with contributions from the National Academies of Sciences, Engineering, and Medicine, will host a virtual meeting to discuss the current state of diversity in clinical trials. (9Dec 10am-1pm ET = 10Dec 2-5am Sydney time)
Health Literacy Hub webinar: Health literacy as a shared resource: exploring the role of family, carers and community in health literacy’. 9 Dec, 12-1pm AEDT. Register online.The Victorian Research Translation Centres (Monash Partners, Melbourne Academic Centre for Health, Western Alliance) are engaging with all relevant stakeholders (including consumers) around the ‘grey zone’ between clinical practice and research. Express interest via this survey in one of the opportunities to engage with this work (including a 10Feb Summit).
Webinar: WHO launches new clinical trials guidance – What do I need to know? 13 Dec, 14:00 CET
The Medical Research Future Fund Australian Brain Cancer Mission is conducting a National Consultation on the refreshed Roadmap and Implementation Plan. Submissions close 20 Dec.
The Australian Clinical Trials Education Centre (A-CTEC) are looking for feedback from users in this15-20min survey that closes 24Dec.
Nominations for the 2025 NHMRC Biennial Awards are open until 31Jan. This include a Consumer Involvement Award.
The international Made with Patients 2025 Awards celebrate individuals and initiatives advancing patient engagement in healthcare, and are open for nominations until 14Feb. (No, these are the not the awards we are planning for later 2025, but still a good opportunity to raise the profile of great initiatives in healthcare :) )

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:

Congratulations to everyone appointed to the National Health and Medical Research Council for 2024-2027.
The Victorian Government Department of Families, Fairness and Housing have released guidance on recognising and reimbursing lived experience experts for their engagement.
Thinking about the HREC conference, I was reminded of the EUPATI Toolbox: Guidance for patient involvement in ethical review of clinical trials
We know patient registeries are a hot topic, so thought this an interesting potential digital course to look at: Patient registries: a practical guide for patient organizations
Test your knowledge of the National Statement: Training guide and quiz on the National Statement for Researchers, from SA Health.
The MRFF priorities for 2024-2026 have been released, and we note the change in terminology from consumer-led to consumer-driven.
We know a number of our community are frustrated by the exclusion of people with disabilities from research. So you might be interested to know the National Disability Research Partnership (NDRP) has announced two rounds of grant funding which will open in 2025, focused on research about the safety of people with disability.
Watch the Appl Clin Trials Peer Exchange webinar: The Importance of Improving DE&I in Clinical Trials (Episode 1)
Listen to the Podcast: Working with Patient Organizations to Use Patient Insights Meaningfully throughout Medicine & Disease Lifecycles
The MRCT Center has launched an updated Post-Trial Responsibilities: Continued Access website, which include a framework of responsibilities for sponsors and researcher to consider in providing continued, equitable access to investigational products. They have also launched a LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Settle into a comfy space for some light(ish) reading:

“I just don’t know enough”: Australian perspectives on community involvement in health and medical research. Res Engage Involv Nov24
Credit where it’s due: Recognising lived experience in research authorship. Pt Education & Counseling, Jan 2025.
Patient and public involvement and engagement: Do we need an ‘ethical anchor’? Res Involv Engag Oct24
Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing. Jul24
WHO Publication: Guidance for human genome data collection, access, use and sharing Nov24
Guidebook: Youth Engagement in Health Research
A thought leadership piece from AIDH: The future of digital health - Progressing the drivers of change. Nov 2024.
OECD report: Health at a Glance: Asia/Pacific 2024 (The health care resources table shows as much as we complain, we are doing better than average across all the high income countries in the region for health spending, and numbers of doctors and nurses per 1000 of population)
Embedding patient engagement in the R&D process of a life sciences company through co-creation with a patient expert R&D board: a case study. Res Involv Eng Nov24
A matrix tool to foster patient engagement in children, adolescents and young adults: report from a multistakeholder workshop. Res Involv Eng Nov24
Building trust and inclusion with under-served groups: a public involvement project employing a knowledge mobilisation approach. Res Involv Eng Nov24
Partnership between a consumer-led mental health research network and a large mental health research organisation: an Australian mixed methods case study. Res Involv Eng Nov24
Patient and public involvement in the design of an international clinical trial: real world experience. Res Involv Eng Nov24
Engaging nursing home residents in clinical research: insights from a patient advisory board, a patient advocate, and a study team. Res Involv Eng Oct24
Training and peer-group coaching for pairs of researchers and patient representatives to support continuous two-way learning. Res Involv Eng Oct24
How should trial teams make decisions about the proportions and diversity of the ethnic groups in their trial? Trials Nov24
Patient-Led Project to Develop Matchmaking Platform to Strengthen Effective Patient Involvement in Research. Europena Patient Advocacy Institute Nov24
Trust: The foundation of health systems. Euro Health Observatory Oct24

Remember to keep an eye on our socials, particularly LinkedIn and our Facebook group for shares and discussion in between newsletters.