A new guidebook explains how rethinking Alzheimer's clinical trials design and delivery can improve the experiences of participants and their study partners.
Alzheimer’s disease is one of the biggest public health challenges of our time and puts enormous strain on individuals, families and societies. Having worked decades in the field, together with our many partners, we know that these challenges can only be overcome through global partnerships and collaborative efforts.
Alongside the wider Alzheimer’s research community, Roche is working urgently to identify possible treatments that might change the course of this complex disease.
Clinical trials are a critical step in evaluating how well a potential treatment might work. Vital to the success of these programmes is the participation of people living with Alzheimer’s, from the start of the trial to its completion, which can sometimes last several years.
“Collaborations between the Alzheimer’s disease community and industry should always be conducted in an open and transparent fashion that respects the independence and specific roles of each of the partners. When interacting with people living with Alzheimer’s disease, particular attention should be paid to supporting them and adapting consultations and interactions to their specific needs,’’ said Jean Georges, Executive Director of Alzheimer Europe.
However, because of their complexity, Alzheimer’s clinical trials face many barriers. When it comes to participation, they rely heavily on the availability of a study partner to support the person living with Alzheimer’s throughout the trial.1
In Alzheimer’s, a study partner is a person who knows the participant and is able to provide accurate information about their daily functioning. A study partner can be a spouse, a family member or a professional study partner. Their role is crucial to support the participant throughout the trial, helping to ensure they are able to complete the trial and that meaningful data can be gathered.2
“Taking part in a clinical trial can be a very challenging experience both for the person living with Alzheimer’s and their study partner supporting their participation,” said Léa Proulx, Patient Voice Partner at Roche. “Study partners can be care partners as well, and as medical progress is an urgent priority for the entire Alzheimer's community, we wanted to understand how trial design could better accommodate participant needs and improve the experience of those involved, from the start, all the way through the trial and beyond.”
Teams from Roche Patient Partnerships, Product Development and Roche's Pharma Research and Early Development (pRED) unit started by asking people living with Alzheimer’s, carers and patient organisations to share their feedback on Roche trials in Alzheimer’s.
“It can be really tough recruiting people to clinical trials in Alzheimer’s and, once on a trial, keeping to a trial schedule can be very challenging for participants. We need to listen and better adapt to their needs in order to keep them on that trial,” explains Ruth Croney, Clinical Programme Leader, Roche UK. “There can be benefits and risks to being in a clinical trial, and as a sponsor, we have a responsibility to make the experience as positive as possible. We wanted to get a fresh view of the wider needs of people living with Alzheimer’s, their care partners and study partners and co-create solutions to improve their joint experiences and participation in Alzheimer’s clinical trials."
Although this view was initially for pRED, it provided the team with some unexpected glimpses into the impact of clinical trials on participants and their study partners, which actually had much broader implications across all Roche Alzheimer’s trials.
Jannice Roeser, Global Patient Partnership Director, Alzheimer's at Roche said, “These conversations highlighted the importance of supporting study partners with care and respect for their own trial journey, so that they in turn can focus on providing emotional support and companionship for the person living with Alzheimer’s. The preparation, getting the person ready, the anxiety, answering questions before the visit, the visit itself and afterwards, dealing with the fallout when they get home such as the fatigue, stress, the ‘sundowning effect’ and returning to their normal routine – this is all additional support provided by the study partner that goes far beyond just that one visit.”
With such valuable insights in hand, in collaboration with the Finding Alzheimer’s Solutions Together (F.A.S.T.) Council, which is sponsored by Roche and includes Alzheimer’s patient organisations, the team developed an internal guidebook for all Roche study teams designing trials.
That guidebook has now been developed further into a comprehensive first-of-its-kind report,
Co-signed and endorsed by eight F.A.S.T Council patient organisations from across the world, the resource is freely available under a Creative Commons licence and is aimed at those involved in trial design, people participating in trials and the wider Alzheimer’s community. It aims to help them:
Better understand people living with Alzheimer’s, their family members and care partners, as well as their journeys and the challenges traditionally faced in clinical research
Design, set-up, recruit for, conduct and follow-up after clinical trials for Alzheimer’s, including guidance on retention barriers and potential solutions
Improve the way that research is carried out for Alzheimer’s
Increase the inclusivity of non-Alzheimer’s trials to people living with Alzheimer’s and their care partners
At the core of the report is the user-friendly guidebook, which includes practical solutions to help make clinical trials a more positive experience, with the objective of improving retention.
“How this evolved and grew was wonderfully organic,” says Ruth. “What we learned was so impactful as it made us take an entirely different view of our trials. It’s already led to a change in our approach when planning clinical trials and how we need to consider a broader, more holistic level of support for care partners as well as participants.
“The guidebook is a living document that will evolve as we continue to learn and partner with the Alzheimer’s community. There are many learnings that can be applied across conditions, but it’s a nuanced process because there are specific considerations that apply to certain populations. We are excited to see how we can expand on what we found across our neuroscience activities.”
Watson JL, et al. Obstacles and opportunities in Alzheimer’s clinical trial recruitment. Health Aff. 2014;33(4):574-9.
Grill JD, et al. Effect of study partner on the conduct of Alzheimer disease clinical trials. Neurology. 2013;80(3):282-8.