CCReW Clinical Trial/Research News 9May23

Dear

We are well into May now, with #clinicaltrialsday typically celebrated on and around May 20. If I know about any events that are open for participation in, they are listed in the events section below. And if you are holding an event but missed the newsletter, still let me know about it and I can share it into the Research Gamechangers Facebook group anytime. That group is where the realtime conversations and sharing happens between newsletters.

I'm celebrating #clinicaltrialsday by sharing quotes daily during May from the community with their human experiences and thoughts about clinical trials. If you haven't caught up with these yet, check out the AccessCR social channels. At the end of the month, I will drop a CCReW blog post with all 31 days of tiles shared. Thanks to everyone that has got involved so far. I am still looking for more quotes. So if you or someone you cared for has participated in a trial (or has wanted to but just hasn't had the opportunity to yet), and you'd like to share your experiences or thoughts on looking for, participating in, the value of / why clinical trials matter (or even what you would like changed), then do drop me a note with how you'd fill in that blank social tile, and how you'd like me to attribute the quote eg to you, anon, etc)

Surprisingly, there was only 1 application for the CCReW travel scholarship to attend the ARCS conference this year, and which will be receiving out support. As such, we are going to partner with ARCS to share the unspent funding to support the travel of a number of the ARCS consumer scholarship holders to attend. Further CCReW scholarships will be offered pending a new fundraising campaign, but I am just holding off on that for the moment to better understand whether these CCReW scholarships are still needed, and for what, or if there is something else the CCReW need more.

By the next time we meet, we will all know what is in tonight's budget. Me personally? Amongst other things, I am hopeful to hear that a "One Stop Shop and Clinical Trials Front Door" of some form might receive funding, such that efficiencies and access to clinical trials can be properly realised!

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 25Apr-9May23 not previously listed here, as at 9May23.

Assessing the IMpact of Alopecia Areata (AA) on PatIents’ and CaregiverS’ in Australia (MARISSA). This observational study with no treatment intervention running nationally is seeking 400 patients (12 years or older) with Alopecia Areata and caregivers of adolescent (12-17 year old) patients to complete a one-time survey assessing the psychosocial and life impacts and disease burden associated with AA.
A First in Human Study evaluating the Safety, Tolerability and Pharmacokinetics of ABBV-CLS-628 in Healthy Volunteers. This 3 part, international, randomized, double-blind, placebo-controlled, Phase 1 first-in-human study running in Victoria is looking for 129 healthy volunteers between 18 and 65 years of age. Healthy first or second generation Han Chinese and Japanese people will be prioritised for participation in Part C.
Risk Directed front-line therapy for Multiple Myeloma incorporating Selinexor: The RIDDLE-M-X trial. This Australian, open-label, non-randomised, phase 2 treatment study running in Victoria is looking for 120 people aged 18 years or older with newly diagnosed multiple myeloma eligible for autologous stem cell treatment (alongside other criteria).
Treating auditory problems in children with neurofibromatosis type 1. This blinded, randomised-controlled, crossover treatment study running in Sydney and Melbourne will recruit 124 children aged 6-12 years with neurofibromatosis type 1 and a functional hearing difficulty.
Treating auditory problems in children with neurofibromatosis type 1: extension trial. This extension study running in Sydney and Melbourne will recruit children aged 6-12 years with neurofibromatosis type 1 already consented to and screened for the parent trial (above).
A Phase II, prospective, open-label, dual-centre, single-arm feasibility study of Pregabalin for the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed. This phase 2, prospective, open-label, dual-centre, single-arm, non-randomised feasibility study running in Sydney is looking for 24 people aged 18 years or older living with advanced kidney disease (end stage renal failure) with moderate to severe Uraemic Pruritus (UP) and chronic itch.
Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults. This blinded, randomised controlled, phase 1 prevention study running in Brisbane is looking for healthy people aged 18-55 years who have received at least 1 dose of a registered COVID-19 vaccine.
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease. This international randomised-controlled, double-blind, placebo-controlled, dose-finding phase 2 study running in NSW, VIC and WA is looking for a total of 240 people aged 50-90 years with a diagnosis of probable Alzheimer's disease.
SODium BICarbonate for Metabolic Acidosis in the ICU. This randomised-controlled, double-blind, phase 3 treatment study running in Melbourne is looking for 500 patients aged 18 years or older in intensive care with metabolic acidosis.

Researcher-initiated listing:

Health Consumers NSW and BEING - Mental Health Consumers have joined forces to draft a survey exploring the attitudes of mental health consumers towards understanding their co-existing physical health challenges. We encourage all our members and everyone with a lived experience of mental health issues to complete this 5-minute survey so we can learn more.

Please contact researchers directly through the listings as we have no connection/involvement with these studies. We'd love to know if sharing these research studies is useful, so please drop us a line to let us know if you contact researchers about them.

If you are a researcher that wants to tell people about your recruiting strudy, please complete our request form or contact us (first listing free, subsequent listings for a fee).

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

Attitude of Gratitude: A TransCelerate Public Webinar - 10 May 2023, 9-10am. EDT. This session will provide an overview of TransCelerate’s Gratitude Toolkit on how sponsors can acknowledge and show appreciation to our clinical trial participants and care partners. Register here.
St Vincent’s Hospital Melbourne are holding a Clinical Trials Awareness Week Panel discussion on: "Patient Engagement in the Digital World" 18May 12-1pm AEST via Teams. If you are interested in attending, please email Research.Direactorate@svha.org.au

WhiteCoats - Your Voice, Your Story. Submit images by 12May, and participate in the webinar on 19 May where clinical trial participant stories will be shared. Learn more.
Celebrate clinical trials day with a live discussion on clinical trial participation with Medidata experts. 18May 4.30pm EST (=19May 6.30am AEST). Register via LinkedIn.
The US Association of Clinical Research Professionals (ACRP) have produced a kit to help clinical research professionals get involved in and celebrate clinical trials day. I reckon there is no reason anyone couldn't use these social posts if they wanted to.
Involve Australia and Australian Genomics- have your say on the draft guidelines for researchers proposing to involve the Community in Genomic Reseach. Involve Australia have developed Guidelines for Community Involvement in Genomic Research and would like to invite you to participate in the survey and provide your feedback on the draft to ensure that the final Guidelines are fit for purpose. Please take the time to have your say. Feedback is due back by either 12 or 26 May (we’ve seen conflicting dates).
Spotted on the Rare Cancers Australia Facebook page: We are collaborating with a team of researchers from the @University of Sydney to develop some new patient resources aimed at supporting and improving the informed consent process for cancer patients who may undergo genomic testing. We are looking for participants to share their thoughts on questions that people with cancer could ask when considering genomic testing, and then to provide feedback on the new patient resources that researchers develop. This will involve two 30-40 minute interviews online. To learn more, please email contact@rarecancers.org.au
The first ever “Made with Patients” Awards are opportunities to celebrate and highlight patient engagement champions and initiatives that go above and beyond in their effort to put the patient at the centre of our health ecosystem. The deadline for nomination is currently set up for 20th of May 2023. Learn more here. (Cheekily, if you think our CCReW initiative is worthy, we'd love a nomination! :) )
Health Technology Assessment Policy and Methods Review – Consultation 1. This is the first consultation of a series related to the review of health technology assessment policy and methods in Australia. For more information, visit the Office of Health Technology Assessment's Consultation Hub. Submissions for consultation 1 close 6 June.
The Patient Engagement Open Forum will hold a face-to-face event in Baveno VB, Italy on Jun 13-15. Learn more here.
Free #NavigatingHealth Community of Practice Webinar 19 Jun 12-1pm AEST: Tests, Trials & Health Care Records (I'll be presenting on accessing and navigating clinical trials).
Monash Partners free webinar 20 July, 1-2pm. Involving consumers in discovery research - reflections and learnings. Register here.

If you'd like to proactively advertise a consumer research involvement opportunity or event, or would like to engage our help or advice on an activity, then please complete our request form or email AccessCR.

Here's a few resources you might be interested in:

The Australian Clinical Trials Alliance (ACTA) recently submitted recommendations to the Australian Department of Health to improve cultural and linguistic diversity in clinical trials.
Reflections on contributing to health research: A qualitative interview study with research participants and patient advisors. PLOSOne 2022.
Cochrane Evidence Essentials is a free online resource offering an introduction to health evidence, and how to use it to make informed health choices. Access the free training here.
How Pre-Clinical Research Contributes to Clinical Trial Safety. WhiteCoats Foundation Apr23.
The NSW Guidelines for Consumer, Carer and Community Member Remuneration were published on Friday 28 April.
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. Check out our latest webpage sharing resources for involving consumers in research.

We're passionate about ensuring every Australian is aware of the opportunities available to them to make a difference through their participation in and contributions to research. So please share and recommend this newsletter and if Facebook is your thing, get involved in our Facebook group for real-time discussion. And if you have any feedback that can help us improve the usefulness of this newsletter, please get in touch. Together I hope we can help speed up and improve medical and clinical research.