Early December I had the pleasure of chairing Plenary 2 at the Australian Clinical Trials Alliance Annual Scientific meeting, entitled 'Consumers at the centre of clinical trials – what does this mean for researchers?'. In a nice change, consumers were front and centre at the start of the event, rather than in the dying throws of the end of the conference. Beyond introducing each speaker for the session, I had the opportunity to lead a panel discussion with some of the rockstars of the consumer world - Karen van Gorp. John Stubbs AM, Dr Shyamsundar Muthuramalingam and Anne McKenzie AM.
In preparing for the session, Anne challenged me to ask the audience, rather than the panel, what's still needed to embed consumer involvement in research, as after nearly 30 years in consumer advocacy, while there has been progress, consumers are not yet widely embraced and involved research. So I reflected alot on that question, and took the opportunity as the panellists came to the stage to reflect on this a little.
So much work goes into preparing conference sessions, which is great for attendees, but what about others that are not in the room? How do we share what happened in the room. To that end, I've decided to share my panel discussion preamble with you as food for thought. And if you have any answers to what still needs to happen, I am all ears.
The Preamble
As we wait for the panellists to join the stage, I hope you don't mind indulging me for a few minutes to share some thoughts before we get into today's discussion, which the panel invites you to be a part of. The plenary topic is consumers at the centre of clinical trials – what does this mean for researchers? But what does that topic mean? It could mean being more patient centric in designing a good experience and outcome for trial participants. It could also mean understanding the rise and importance of the patient voice in research, and how researchers are going to work with it.
I came to start talking to patients in my efforts to try and understand how to improve the efficiency of trials from an operational perspective. Talking to lots of people, I really think there is alot we can learn from community if we just ask. And so I want to perhaps challenge the premise of the title of this session, which suggests the case has not already been made for researchers to partner with consumers. I like to move us from 'what does this mean for researchers', to 'how can we as researchers effectively embrace the opportunity to get the best bang out of our research dollar, to solve the problems that really matter to patients, and do that efficiently'. Because that’s what partnering with consumers actually means for researchers – achieving all those things.
ACTA have drawn together this panel of illustrious consumer advocates, one of whom challenged me to be deliberatively provocative today, to try and push us past the same old conversation about why, to why not – what needs to happen to make this business as usual?
What I love about working in the clinical trials is working with incredibly smart, passionate people, focussed on giving people better quality, longer lives. Now in the patient engagement space, I am inspired by the equally matched drive and passion of people with lived experience to improve the care and lives of others, from very informed positions. What an untapped potential there is if we can only get these two groups to be collaborating meaningfully and effectively together to solve issues in the health and research systems for tomorrows patients.
I believe in clinical trials for their ability to give people more time with those they love. For myself, I lost my father at 18 to melanoma. At that time, the statistics were pretty grim with 1 in 5 stage 4 melanoma surviving past 5 years, and now its something like 4 in 5 with many even being ‘cured’. Clinical trials do good.
Having listened to many stories from people with lived experience (either their own or that of those they care for) over the years, there can also be collateral damage from clinical trials, which we really fail to look for or understand. Patients don’t generally complain, because they don’t want to seem ungrateful for the opportunity, especially where they have also experienced benefits such as a longer life.
The financial imperative to industry in involving patients early, has been made. In a 2018 study published by the Clinical Trials Transformation Initiative1, engaging patients at phase 2 could result in as much as a 500x return on investment on $100,000 as a result of improvements reducing the burden of participation, improving recruitment, reducing time and avoiding protocol amendments. While that ROI is not necessarily as important to the non-commercial trial groups, the shortage of funding is very pertinent… imagine if those efficiency gains demonstrated for industry were applied in investigator led research, reducing waste. How many more research projects might actually be able to be funded? Tax payers want their funds used efficiently. There are so many unmet patient needs. We have a responsibility to ensure we are getting the most out of every dollar invested in clinical trials. That's how we will retain the trust and social licence of the public to keep investing in research.
And so I think we can do better. No other industry would consider developing products and services without a firm lens on what the consumer wants. I am not sure why we are so indulgent in the health and research sector as to think we can solve patient needs without patients as partners in how we do that. That is not to say clinical trials don’t currently deliver better outcomes – they are delivering. But imagine if we could do it more effectively, meet more patient needs, and faster – all the things involving consumers has been shown to do.
As Anne reminded me last week, consumers submitted to the Wills Review in 1998 on the need for a consumer voice in research. We’ve had a version of the CHF-NHMRC Statement on Community and Consumer Involvement in Health and Medical research since 2002. Consumer-led/driven research has been an MRFF priority since at least 2018. We’ve had a Partnering with Consumers quality standard in healthcare since 2011, which states that consumer involvement contributes to appropriately targetted initiatives, efficient use of resources and improvements in quality of care. It makes sense therefore that the National Clinical Trials Governance Framework, launched in 2022, requires integration of that Partnering with Consumers standard into clinical trials run in accredited healthcare organisations. Research funders are increasingly requiring demonstrations of consumer involvement in grant applications. And just last week (26/11), the paper released from the National Biotech and Medtech Development and Commercialisation Summit on the 19 Nov in Canberra reported as a central theme of all the day’s discussions ‘the need to embed community voice and perspective for successful translation and commercialisation of patient-centric innovations’. As Karen has just stated, the HTA Reform Review and Enhance HTA reports have clearly referenced the importance of early engagement of consumers in clinical trials.
As if all that domestic signposting isn't enough to tell you the 'why' case has been made, then there are also plenty of signals in the international environment. The 77th World Health Assembly in May adopted the resolution 'Social participation for universal health coverage, health and well-being', which reiterates the importance of public participation in the development and implementation of policies and plans that have an impact on health, and the need to implement, strengthen and sustain regular and meaningful public participation in decision-making processes for health. The October update to the Declaration of Helsinki had a number of substantive changes that were participant focussed, including calls for community engagement in trials. ICH E8 - General considerations for clinical trials - suggest consumer involvement as helpful to ensuring quality by design, and the upcoming ICH E6 (R3) (otherwise known as the third renovation of GCP) is expected to reference a need for public involvement.
I’ll be honest and say I’m impatient for a change for which I think the case has been made and just makes sense. Fair play to people like Anne who have been doing the hard yards much longer than myself. I found my way into consumer engagement because I was curious about the participant and patient partner experience. Researchers are naturally curious. They will toss around ideas with their colleagues and interrogate the research literature, Yet, there is an apparent reluctance to engage with those they are so desperate to help.
So I am curious.
All the environmental factors seem to be there. There is a plethora of resources, toolkits, training and guidelines pointing toward it. We have seen some change over the last decade or so, but it is slow. There are different levels of maturity in the space, so how do we get the leaders to bring those less ready to the table?
What else needs to happen, either at a policy, funding, regulatory, cultural or practical level to make consumers a partner in clinical trials, in the same way statisticians and data scientists and all the other members of the multidisciplinary team we know just need to be there. Is it funding, or is it will, or is it some other practical element we are still missing? Reflecting on Professor Marion Campbells earlier presentation, do we have the capability, the opportunity, the motivation to involve consumers?
When we look around the country at where community and consumer involvement in research has been embedded, for example WA, the availability of funding has been one facilitator, but so has leadership and will. There are many researchers that have worked with consumers long before funders required it, because it just made sense – it focussed research on the problems patients needed solved, rather than what clinicians felt patients wanted solved.
So I am going to ask the audience for your view, and to give you a few mins to think about that, I am going to ask the panel the same thing… is It funding, is it will, is it culture, is it about formal change-management and power dynamics, or is it something more practical about the infrastructure for CCI – what’s going to move this from a cottage activity to the way we work, in a way that is financially, emotionally, practically sustainable for both the research and consumer workforces? What will make it so easy to partner together, that it isn’t given a second thought? What is needed from the consumer perspective in a few words, before I go to the audience for the researcher perspective on getting beyond the standard questions of why involve, where do I find consumers and what do I do with them, and the usual justification ‘I’m not funded for this’.
So while the panel discussion didn't resolve any of these questions, I would like to thank ACTA for the opportunity to chair the discussion, and the rockstar panel for pushing me to think about these questions. It has planted seeds for 2025, but more on that to come 🙂
I encourage you to keep an eye on the CCReW Newsletter for more to come and your opportunity to tell us what you think is needed, as well as to celebrate and be inspired by the excellence that already exists.
