CCReW Research News 5Dec23- Australia

Dear

So we've made it to the last newsletter of the year (as I am sure no-one wants more email the week before Christmas)! I'd like to thank each of you who have subscribed and regularly opened our newsletter each fortnight - typically over 40% of subscribers each edition. I am also grateful to each of you who have supported and engaged in our other channels and activities, like the Facebook Group, the CCReW scholarships, the #ptinclusiveconf advocacy and the shop. You help fan the flame of my passion for this work and keep it alive, inspiring me with your own journeys and achievements.

Yesterday, I had the opportunity to be in my happy place out in the community talking about clinical trials. This however was the first time I was invited to speak to a group via an interpreter. When we are looking to increase the diversity of people taking part in trials, making sure we are meeting people where they are, in the environments and language they are comfortable in, and understanding their specific concerns, is both necessary and a privilege. Thankyou to CanRevive for this experience.

With the year wrapping up, there are less trials starting and less opportunities to get involved in research listed below. I imagine they'll start ramping up again early next year, so I plan to restart the newsletter late January. In the meantime, anything I hear about will be shared with the Facebook group, and I encourage others to also keep sharing their opportunities and resources with that community. I'll be using 'the break' for a little rest and recouperation after a particularly challenging 6 months personally, and amongst other work, thinking about what's next for CCReW and AccessCR. Feel free to reach out if you have any burning ideas around consumer participation and involvement in research YOU think need focus in 2024.

This is a list of all studies on the ANZCTR approved by a human research ethics committee, that opened to Australian participants since 20 Nov 23, as at 4Dec23. We've highlight the broad population that studies are looking for, and where, so please click the link for full trial details and eligibility.

Cancer

A Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants aged 18 years or older with PD-L1 positive locally recurrent inoperable or metastatic triple-negative Breast Cancer. [VIC, NSW, WA]

Healthy Volunteer

A First-In-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Volunteers aged from 18-55 years. [SA]

Other

Waiting time: Does it affect the physical functioning of people waiting for a total joint replacement? This study will seek people aged 18 years or older who are on the public waiting list for primary total hip and knee replacements at Royal Adelaide Hospital. [SA]
What is the effect of wearing a surgical mask or an N95 mask on patients aged 18 years or older on non-invasive ventilation for the treatment of stable chronic hypercapnic respiratory failure for at least 28 days? [NSW]
A two-stage phase 2/3 study to assess the efficacy, safety and pharmacokinetics of Alpelisib in paediatric and adult patients (aged 2 years or older) with lymphatic malformations associated with a PIK3CA mutation. [QLD]
A Phase 2 study to assess the safety and effect on pain and function of IHL-675A in patients aged 18 years or older with Rheumatoid Arthritis. [ACT, NSW, QLD, VIC, WA]
A study to assess if giving Dapagliflozin compared to placebo decreases injury to the kidneys in patients admitted to the Intensive Care Unit. [VIC]

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:

If you want to be at HTAi 2024 Seville, don't miss the closing date for HTAi Participation Grants - this Thursday, 7 Dec (Mountain time)
The Garvan Institute (Sydney) are holding a public seminar 8 Dec 10.30am-12pm: A year in review, reflecting on some of the research highlights and breakthroughs of 2023. Register for online or in-person attendance.
The VCCC and partners are inviting consumers, researchers and health professionals interested in engagement practice to come together for an exciting Consumer Engagement and Leadership Forum Friday 8 Dec 10am–12pm in Melbourne. Register online
There is a free meeting (US based) entitled the State of AI in Precision Oncology on 13 Dec 3-8am AEDT. Register online.
The National Health and Medical Research Council (NHMRC) and the Department of Health and Aged Care (the Department) (responsible for implementation of the Medical Research Future Fund, MRFF) are developing a Statement on Sex, Gender, Variations of Sex Characteristics and Sexual Orientation in Health and Medical Research (the Statement), reflecting a joint commitment to health equity, and acknowledging that every person in Australia has the right to be included in safe, high quality research that informs our health care. Public consultation on the Statement is open until 15Dec.
St Vincent's Hospital Melbourne are looking for members of the community to join their Human Research Ethics Committees (HREC). For more information and contacts, review the LinkedIn post that prompted this listing.
We all know participation information sheets and consent forms for clinical trials need improving. Provide your feedback on the beta-testing versions of a new potential Australian template, developed through a CT:IQ project, available at www.informedpicf.com.au. Consultation is open until the end of the year.

CT:IQ is currently asking for feedback from researchers about how they communicate wtih their trial participants throughout the research, and feedback from consumers about their experiences of communication in trials. As we are part of this project, we really encourage you to participate so what matters to you as trial participants gets recorded.
The National Health and Medical Research Council (NHMRC) and the Consumers Health Forum of Australia Ltd (CHF) are collaborating to review the Statement on Consumer and Community Involvement in Health and Medical Research (2016) (the Statement). A Consumer Statement Advisory Committee have been established and a position paper released (available in the downloads section of the ‘be part of the conversation’ tab that appears to have a number of discussion questions. It is not clear the timelines or process for consultation, but there is a form you can complete to be updated on the progress of the Consultation. We’ll be keeping our eye on this.

Here's some other news and resources you might be interested in:

Researcher Perceptions of Involving Consumers in Health Research in Australia: A Qualitative Study.
UK’s strong public support for diversity in research. 21Nov23.
A video recap of the ACTA Nov23 conference, highlighting the value of the conference (with a nod to the consumer involvement at it).
What matters to you? Engaging with children in the James Lind Alliance Children’s Cancer Priority Setting Partnership. Res Engage Involv Nov23.
Setting Industry Standards for Patient Engagement, Partnership, Allyship and Care: The Patient Vision Project. Blood Nov23.
Who Cares for the Patient Advocates? Sue Robins, Nov23.
Paper on the Global Patient Experience Data Navigator, a tool co-created by Patient Focused Medicines Development to provide practical resources that can facilitate and optimize patient experience data generation, collection, analysis, and dissemination for patient benefit and aims to be applicable across all therapeutic areas for all stakeholders.
International guidelines on good governance practice for research institutions. CIOMS Dec23
Presentations from the 4th annual HREC conference are available online. I only got to attend a few sessions over the 3 days, but they were really fabulous, and plenty of talk of consumer engagement.
The long awaited Government response to the 2021 report: The New Frontier: Inquiry into approval processes for new drugs and novel medical technologies in Australia was released at the end of Nov.

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. We also have a list of some resources for involving consumers in research.