CCReW News 1Aug23- Australia

Dear

I've been a little quieter over the last couple of weeks taking some time out for my health. Here's a few things that have caught my attention recently.

I engaged last week in an online webinar led by Health Consumers NSW (HCNSW) discussing the NSW Health Consumer Remuneration Guidelines and the nuances of applying them. There is a tricky balance to walk between volunteerism, exploitation, and inclusion/exclusion and some unresolved issues around tax/super/compliance, etc. So I think it is really important that we keep openly discussing these issues. In my view, it is always right to offer compensation/ remuneration for time and expenses, to allow someone to choose if and how to accept that offer, and that the process is made easy. If you are looking for a list of resources on compensating consumers, you'll find those we know about from around the country on the AccessCR website. And to view the webinar, access it via the HCNSW online community. If you are finding that the process or paying consumers (or getting paid as a consumer) is a particular pain point, please reach out for a discussion.

In preparing for the next ARCS Consumer Partnerships Interest Area meeting I've been thinking alot about the room for improvement there is in how we communicate information throughout the therapeutic lifecycle to the relevant consumers. From protocols, to recruitment, to consent, to support, to summarising, sharing and using the outputs of research in care, health technology assessment, health education... how can consumers effectively contribute and partner with trial sites and industry to improve these communications. What are the benefits of using plain language, and how can we use it more? What's holding us back on preparing and working with consumers in these areas? What are consumers already doing? I've dropped a few of the plain language resources I've found that are useful in the resources below, and encourage people to share others they like in the facebook group so we can share them in the meeting. It should be an interesting discussion, and I hope you will register when ARCS launches that in the next few days.

Registrations have opened for the #PXP23 free virtual conference 12-15 Sep. This is a patient/consumer-led international conference and will be discussing all things related to consumer engagement/ involvement. There are sessions scheduled the means people in all the timezones will be able to attend at least some part of the program. For information, I'll be moderating a discussion at 8am AEST on the 15 Sept. The website is now up so you can register. Recordings will be made available to everyone registered. And usefully, there is growing resource library that is going to be a fab source for consumers and research alike to refer to.

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 3-17Ju123, as at 17Jul23.

Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment in patients with lymphoma. This open-label, randomised controlled rehabilitation study running in Melbourne is looking for 38 people aged 18 years or older who are in remission having completed chemotherapy for aggressive lymphoma within the past five years, and have perceived reductions in cognitive functioning.
Early Feasibility clinical study of the FloStent System. This open-label, single group, non-randomised study running in Wollongong and NZ is looking for 40 men aged 45 years or older with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
Feasibility of an intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT) – an Acceptance and Commitment Therapy (ACT) based transdiagnostic approach. This randomised, blinded, waitlist-controlled pilot and feasibility study recruiting nationally (and based in Melbourne) is looking for 120 people aged older than 17 years with access to telehealth facilities and meeting the case definition for Debilitating Symptom Complexes Attributed to Ticks (DSCATT).
The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep in healthy adult males. This blinded, randomised controlled treatment study running in QLD is looking for 21 healthy males aged 18-40 years without known sleep disorders/disturbances and who regularly consume caffeine.

For noting, if you are interested in a study, and it is not running near you, please contact the researchers in case there are other options or support with travel to participate.

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 sponsor or researcher that wants to let people know about your newly opened study, please complete our request form or contact us (first listing of a study/event is free, repeat listings for a fee).

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

The Department of Health are holding a webinar about the Medical Research Future Fund's (MRFF) Principles for Consumer Involvement in Medical Research 3 Aug 12-1pm AEST. Register online.
Invitation for public submissions: Australian Clinical Guideline for Physical Rehabilitation and Mobilisation in Adult Intensive Care Units. Monash University has released the new guideline recommendations for public consultation ahead of seeking NHMRC approval of them. Submissions close Friday 18Aug.
VCCC Webinar 21Aug 1-2pm: Ethics and biobanks. Biobanks have great potential in advancing population health research by enabling access to biospecimens that can be linked to health data. In this webinar, a multidisciplinary panel featuring Clinical Ethicist, Professor Clare Delany, will explore the opportunities and challenges of linking biospecimens to health data in health research through the lens of ethics and consumer rights. Register online.
The Patient Voice Initiative are hosting a webinar about their recent research on how patient communities want to interact with pharma on 24 Aug, 12.30pm AEST (which I will also be participating in). Register free online.
ARCS Consumer Partnerships Interest Area webinar 29 Aug, 12.30pm AEST - discussing consumer involvement in preparing communications across the therapeutic lifecycle. Save the date and keep an eye on our/ARCS Australia socials for more details on registering.
Consultation on the Draft National Consumer Engagement Strategy For Health And Wellbeing: The purpose of this Strategy is to mobilise a person-centred prevention system by involving communities and consumers in preventive health policy design and implementation in order to enable and support a more engaged population and improved health outcomes for all Australians. Consultation closes 4Sep23.
The 3rd revision to Good Clinical Practice (the international guideline for the conduct of clinical trials - ICH E6(R3)) is currently open for global consultation. Though there is no specific Australian consultation deadline, there is the ability to contribute to consultations being undertaken by other regulatory agencies, with deadlines ranging from late Aug – Oct. Learn more by clicking here and navigating to E6-Good Clinical Practice, then E6(R3) EWG on the drop down menu .
The HTA Review Reference Committee have opened up expressions of interest for deep dive discussions with them, so read more here and apply by 1 Sep if this is of interest.
The VCCC are holding a comprehensive cancer conference in Melbourne 12 - 13Sep. Today, they have announced there is a discounted consumer rate of $325 for 2 days, $225 for 1 day.
Attend the #PXP23 free virtual conference 12-15 Sep.
The World Health Organization (WHO) has invited comments on its draft guidance on best practices for clinical trials, which was produced at the request of the World Health Assembly as part of last year's Resolution WHA75.8 on Strengthening clinical trials. The deadline is 15 Sep.
The Patient Engagement Open Forum 2023 (PEOF) are holding an online event 4 Oct, 1.30-3am AEST on “How can we foster publications on Patient Engagement (PE) initiatives?’. Register online.
For the first time, Australian women are invited to share their experiences in the health system to better inform policy development and improve health outcomes for women and girls. An Australia-wide community consultation project has begun to understand the personal experiences of bias in the health system. Anyone can take part, including patients, health providers, researchers and other stakeholders. The survey closes 13 Oct.
2023 WCG Online Patient Forum 26 Oct, 3-6am AEST. Listen to the voices of patients, their families, caregivers, patient advocates, and health care professionals, sharing their trial experiences and stories regarding a range of issues in clinical trials.

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. (Consumers will be asked in the near future about their experiences of communication in trials, so stay turned).

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

PrOSPeCT (Precision Oncology Screening Platform Enabling Clinical Trials), a $150 million joint initiative by the Commonwealth, the NSW Government and industry partners, has launched this week. It will provide 23,000 patients battling incurable or advanced cancers with better access to treatments that could save or extend their lives. Learn more here.
Advarra have released an infographic with the results of a 1000 person US-centric survey on perceptions about clinical trials. Most of the results would be consistent with information we've seen or heard from Australians, though it is interesting how highly financial compensation sits as a motivator for the population surveyed (which isn't something raised here often).
MRCT 2 hour webinar recording: “Time to Listen: Hearing from Young People in Clinical Research,” focuses on the perspectives of young people and the adults who care for them in clinical research and product development.
UK NIHR Case study: Managing difficult situations in patient and public involvement
Storytelling for impact: the creation of a storytelling program for patient partners in research. Res Involv Engage 25Jul23
Determining the benefits and drawbacks of parents using personal connections and social networks for recruitment in research projects: a qualitative study. Res Involv Engage 26Jul23
Reporting involvement activities with children and young people in paediatric research: a framework analysis. Res Involv Engage 31Jul23.
The University of Sydney's Health Literacy Lab have excellent tips with links to really useful tools for improving the readability and presentation of texts for lay audiences.
Step by Step Writing Guide for Developing Plain English Consumer Information. NSW Health Illawarra Shoalhaven LHD
Writing health information for consumers. Health literacy fact sheet 4. Australian Commission on Safety and Quality in Health Care
How to meaningfully involve children in research. The Conversation, Aug 21
MRCT Clinical Research Glossary - 53 plain language descriptions of clinical research terms (with 118 additional terms in the works).
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.