CCReW Research News 1May24

Dear

Who else has been busy through April? Easter, school holidays, consultations, and yet more consultations. Check out those still looking for input this month in the Opportunities section below, as well as the online chat we'll be having on Mon 6 May for anyone that might like to talk further about the National Community and Consumer Involvement in Health and Medical Reseach Statement review. And if you are interested in what we submitted for the consultation on an Enhanced Consumer Engagement Process for Health Technology assessment, its now on the CCReW blog.

May is a month to celebrate clinical trials. It's a perfect time to think about thanking those that participate (as well as all the staff that work in them), helping advance healthcare safely for us all. If you need ideas, our Origami Sunflowers (in kit form or made up) will not only brighten someones day, but it will help us sustain our efforts to support CCReW. Also, keep an eye out for event in and around International Clincial Trials Day (20 May) - a few of which are listed below, include out 'Clinical Trials Explained webinar on the 24 May.

The next Sydney CCReW meetup will be for dinner in Darling Harbour on the 13 June. I'd love to meet any of our consumer community involved in research that might be in Sydney that day, so please register for a ticket.

The following is a list of trials from ANZCTR listed as having started recruitment between 20 May and 30 Apr 2024 (as at 30 April). For more details, click on the links to access the spcific trial information.

Cancer

Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer. NSW, QLD, WA.
A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy. QLD, SA, VIC.
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy. NSW
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors. VIC.
A Phase 2 Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004). NSW.
A Phase 2 Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005). WA.
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation. SA, VIC.

Diabetes

A Seven Day Study of the SynerG Combined Insulin-Delivery and Glucose Sensory System in Persons with Type 1 Diabetes. VIC
Pilot trial assessing antibiotic duration in diabetic foot ulcers that probe to bone. VIC
Examining the effectiveness of a Meta-Health Clinic: Exercise, diet and lifestyle education to manage cardiometabolic health, quality of life and pain in people with type 2 diabetes and osteoarthritis. NSW.
PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial. NSW, QLD, SA, WA, VIC

Infections + Vaccines

Anorectal Chlamydia Trachomatis infection in asymptomatic women who present to regional North Queensland Sexual Health Services. Townsville, Mackay QLD.
WNTR-VZV-001: A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Solexan™ when Administered Topically to Acute Varicella Zoster Virus (Shingles) Lesions. NSW, VIC
The effect of access to point-of-care full blood examination testing on time to treatment for sepsis in Northern Territory primary health care settings. NT
A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults. ACT, NSW, QLD, VIC
A Phase IIb Study of an RSV Vaccine Candidate in Adult Participants 60 Years and Older. NSW. VIC, QLD.
The Osteoarthritis Prevention Study (women age 50+). NSW.

Kidney Disease

Kidney-Healthy Eating and Lifestyle Program (Kidney-HELP): Randomised Feasibility Study in Adults with Chronic Kidney Disease. QLD.
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. VIC, NSW, WA, QLD
A Phase 3 Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN). NSW, ACT, VIC, QLD, SA
Spatial Transcriptomics in Kidney Transplantation. NSW.

Infant/Paediatric/Adolescent

The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy. VIC
Phase 3 Study of ALXN1850 in Pediatric Participants With Hypophosphatasia (HPP) Previously Treated With Asfotase Alfa
Optimising Respiratory Support in Rural and Remote Settings for Children. QLD.
A Phase 3 Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta. VIC, WA.

Healthy volunteers

Bioequivalence Assessment of Topical Smartech 2% Diclofenac Sodium Solution Compared to a Reference Product When Applied to the Knees of Healthy Male and Female Participants. Adelaide SA.
The effect of refeeding strategies on body composition and resting metabolic rate of physique athletes post-competition. ACT, NSW.
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects. SA.

Other

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease. WA.
Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease. WA.
A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients. NSW, QLD, SA, WA, VIC
Estradiol for the treatment of anorexia nervosa. VIC
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease. NSW, QLD, VIC, WA
Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment. QLD.
Effect of the HIRAID (Trademark) Aged Care Nursing Framework on the Quality and Safety of Residential Aged Care. NSW.
A study of the Volt™ PFA system for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation. SA, QLD, VIC
A Phase 1 Study to Evaluate ADX-850 in Participants With Hypertension. SA, WA.
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation. NSW, QLD, VIC, WA.
A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia. VIC, WA.
A Phase 1b Study of Aerosolized RSP-1502 in Subjects With Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection. NSW, SA, WA.
Abdominal bracing for adult acute low back pain in the Emergency Department: A randomised controlled trial exploring impact on pain, function and healthcare use. WA

We have no connection/involvement with these studies, so please open the links to get the contact details for the study. 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.

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).

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

RSVP by 1 May to attend ACTA's 2024 Trial of the Year awards (free) in Sydney on 20 May, 4.30-7pm.
Apply to join the St Vincent's Hospital Melbourne Human Research Ethics Committee as a lay member.
Attend one of the last in person or online consultation workshops being over the next week by Australian Health Research Alliance partners on the National Statement on Consumer and Community Involvement in Health and Medical Research. Full list of dates and links here. (Or join the AccessCR online chat with community members on the 6 May 1-2.30pm).
White Coats Foundation are looking for people to share their stories about clinical trials for their clinical trials day event Your Voice, Your Story.
Celebrate International Clinical Trials Day on 20 May by attending an event like one of these:

Hear about Hunter Medical Research Institute's Trials, 9am (in person)
Visit Queensland Childrens Hospital (the Pink Bunny) from 11am for a sausage sizzle, interactive displays and games
Learn about La Trobe University's Trials, 11.30am (in person)
Explore 'Patient Recruitment and Retention' at https://www.linkedin.com/posts/tamcnguyen_clinicaltrials-healthcare-patientfirst-activity-7184301691821854720-zA1L?utm_source=share&utm_medium=member_desktopSt Vincent's Hospital Melbourne 4-5.30pm (in person or virtual)

Learn more about clinical trials at our 'Clinical Trials Explained' webinar, 24 May 12-1pm.
Complete the NHMRC consultation survey on the National statement on consumer and community involvement in research by 31 May.
Come along to our Sydney CCReW meet-up for dinner in Darling Harbour, 13 Jun. All consumers with an active interest in partnering research are welcome.
Submit an abstract for the FECCA Conference in Brisbane from 16-17 Oct. Due by Fri 28 Jun.

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

Share messages about clinical trials all though May to help raise awareness. Need inspiration? Check out our social posts, or social post templates from SoCRA, ACRP, IACRN or follow hashtags like #clinicaltrialsday, #ICTD24, #ICTD2024, #CTD24, #CTD2024 for content to share.
Read (or listen to) Rebel Health, a book outlining the patient-led revolution in healthcare, for a bit of inspiration.
Follow Sue Robins on LinkedIn or X - we're a relatively new follower and are loving some of her down to earth patient engagement posts.
Grab a glass of your favourite liquid and settle in to read some of the following thought providing posts and articles:

So you say you want patients as partner in research eh? This discussed the challenges experienced by patient partners working with a research team to apply for a grant in Canada. This sparked quite the conversation in our Research Gamechangers group for the similar experiences with NHMRC and MRFF grant applications.
'The Patient' - what happens when someone is reduced to being a nameless patient. Terminology and compassion matter.
Differences in cancer clinical trial activity and trial characteristics at metropolitan and rural trial sites in Victoria, Australia - great data for those advocating to make trial more accessible to rural Australians.
Community engagement is critical — but it needs to evolve — Here’s how.
Patient and Public Involvement - Stranded on the Adoption Curve? What do you think?
Shining a light on the road towards conducting principle-based co-production research in rehabilitation
Reimagining the Research Landscape: A Mar 2024 report by Canada's Patient Advisors Network sharing patient partner experiences and thoughts on how SPOR/CIHR could modify practices. Plenty in there for the MRFF and NHMRC to consider too I suspect!
Engaging Internal Stakeholders to Embed Patient Engagement in a Meaningful Way that Drives Value for All
Pressure: How to meaningfullly engage with patient stories

Review the recent webinar resources provided by Health Translations Queensland on data governance, especially those on Indigenous data sovereignty.