CCReW Aus Trials & Research Involvement Opportunities/Events 5Jul22

Dear

In the past fortnight, I've been part of a consultation group providing feedback on standard fields for inclusion in the WHO-International Clinical Trials Registry for reporting of clinical trials. Its an ongoing process, and what is clear is that there is a balance to be sought in the type of information that should be included. I'd love to hear what the CCReW would be interested in seeing reported from clinical trials on registries, so feel free to drop me a line if you have any suggestions.

Given Australia's current concept for a National Clinical Trials One Stop Shop includes a system that would prefill a new generation trial registry, it will be important to consider how uploading and sharing of trial results may also be facilitated by that system?

In other news, CCReW member Vanessa recently shared her experience looking for and participating in a clinical trial in a webinar for other people to learn from. Read more about why she did this, and access the webinar and resources here.

In closing this week, with terrential rains yet again lashing parts of NSW and QLD, I just wanted to send my heartfelt prayers and support to those facing their third flood and cleanup this year. Be safe, and I wish you the resilience to get through yet another challenge. If anyone is looking for a way to help flood victims, these NSW and QLD government websites provide some useful links.

Wishing the next fortnight is kind to you all.

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 20 June 2022, as at 4Jul22.

The Effect of Exercise on brain health in Breast Cancer Survivors. This pilot study at a centre I QLD is looking for 24 female breast cancer survivors aged 50-80 years who have completed their primary treatment.
A Two Part, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GXV-001 in Healthy Volunteers. This Phase 1 safety study at a centre in QLD is looking for 88 healthy volunteers aged 18-40years.
A Mixed Methods Early Evaluation Study To Assess The Safety, Efficacy and Usability Of A Point of Care Peritoneal Dialysis System When Used By Patients In The Home. This study at centres in Sydney NSW is looking for 28 patients aged 18 - 80 years (inclusive) and treated with peritoneal dialysis for a minimum of 6 months OR clinicians (physicians or nursing staff) with at least 12 months experience of peritoneal dialysis.
REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): a multi-site feasibility randomised controlled trial. This study with centres in Sydney NSW and Melbourne VIC is looking for 180 people aged between 50-75 years with mild-severe obstructive sleep apnoea and new onset cognitive decline within the last 5 years.
A phase 2 study of de-escalation in resectable, locally advanced cutaneous squamous cell carcinoma with the use of neoadjuvant Pembrolizumab. This study is looking for 27 people aged 18 years or older with a confirmed diagnosis of invasive Squamous Cell Carcinoma (SCC) of the skin, and are a candidate for surgical resection and/or post-operative radiotherapy.
A Phase III, international, multi-centre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin over 14 days for opioid unresponsive cancer-related neuropathic pain. This study with multiple centres in NSW, QLD and VIC is looking for 180 people aged 18 years or older with a diagnoses of cancer and neuropathic pain taking stable regular pain medication.
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling. This device study is looking for 20 people internationally about to undergo angiographic and endovascular intervention with specific cardiovascular issues. In Australia the trial is running at a centre in Perth WA.
A Study of Monepantel in Individuals With Motor Neurone Disease. This phase I tolerability, Safety, pharmacokinetics and preliminary efficacy study is looking for 12 people with Motor Neurone Disease and a competent caregiver to help with administering the study drug. The trial is running in Melbourne VIC and Sydney NSW.

Other trials (posted at researcher's request) - Once-off free listing:

Prenatal Iodine Supplementation and Early Childhood Neurodevelopment (PoppiE). This study with centres in SA, NSW, VIC and QLD is looking for 754 pregnant women from around Australia who are ≤13 weeks pregnant to take vitamin and mineral supplements with different amounts of iodine to determine the optimal amount of iodine needed during pregnancy for baby’s development. Contact: poppie@sahmri.com or 0428 642 471

To learn more about any of these studies, please contact the research teams directly (details will be in the links). If you have problems contacting the researchers, please let us know. AccessCR has no relationship with any of these projects and conducts this search of the public register to help people know as soon as possible about the research looking for participants.

If you'd like to proactively advertise a research study, then get in touch. The first listingof a newly recruiting study is free, and subsequent listings are available at a small cost. Advertising your trial will help CCReW know about it, and help us sustain this free CCReW support service.

Have you ever been asked about your experience participating in research?

Our concept research participation experience survey is online for anyone that would like to keep a record of their experiences over time. It can be completed at any time, from trying to access a research study, to participating and completing the study, and as often as you like. You will be emailed a copy of your responses to do with as you wish.

Telling us about your experience will also help us identify opportunities for improvement, or centres giving great experiences to participants that others might be able to learn from.

The following are some activities that have come across our desk that people may be interested in contributing to:

Dr Hazel Jenkins, Macquarie University NSW, is looking for a health consumer partner to be an associate investigator on a Low Back Pain project. This is an opportunity to join the research team on a grant application for research funding through the MRFF Clinician researchers scheme. The project will investigate whether a patient education intervention can reduce unnecessary imaging and improve management of low back pain in general medical practice. For more information, email: hazel.jenkins@mq.edu.au
Via Dr Dawn Richards, Canada: Our team is looking for your insights about COVID19 recommendations and how they're written & presented. This is open to anyone >21 years of age (anywhere in the world). surveymonkey.com/r/HSMPN86
Join in shaping the future of patientengagement and patient experience data. Anyone can participate in a public consultation being conducted by PFMD.org for the first Global Navigator for patient experience data. Click here for more information.

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