Successful recruitment of patients is one of the most challenging aspects of conducting randomised clinical trials.
Novartis and its research partners, Amgen and Banner Alzheimer’s Institute, are on a mission to find people who have no symptoms of Alzheimer’s disease to take part in research.
If you live to 85 years old, which most of us hope to, you have a one-in-three chance of getting Alzheimer’s or some form of dementia. It’s a reality that comes into sharp focus when you consider it’s the leading cause of death in England and Wales (ONS data, 2016) without a treatment to prevent, cure or slow its progression. That’s why it’s essential that researchers work together and with the public to overcome the challenges associated with recruiting volunteers for long-term studies conducted before the onset of disease symptoms.
To recruit over 3,000 participants, we need to start with a pool of people who are in the right age bracket (60 to 75 years) and are willing to have a cheek swab test to find out if they carry a specific APOE genotype that increases their risk of developing Alzheimer’s symptoms. Importantly, we then need to make sure they are cognitively asymptomatic. In other words, Alzheimer’s may not even be on their radar and they need to be able to appreciate what it may mean for them to identify this risk.
Additionally, the demand for participants for Alzheimer’s research is at an all-time high. Right now, there are more than 20 Alzheimer’s studies recruiting volunteers in the UK. Yet these trials, like hundreds of others around the world, face drawn-out periods of recruitment and high drop-out rates.
Increasing the number of potential participants
The first obstacle to overcome is to increase the pool of potential participants. A recent survey showed that there is a low trial awareness and understanding of how to volunteer, which is likely to have a negative impact on research. It’s not all bad news though, as the survey demonstrated high levels of public willingness to participate in research.
Focusing efforts in the pre-symptomatic setting requires that we not only consider recruiting from traditional settings, such as clinic databases but also non-traditional settings such as community centres and public domain websites. Trial sites work closely with memory clinics to enrol participants with Alzheimer’s or other forms of dementia, however these clinics are also looking at ways to attract volunteers without symptoms. For example in London, the Imperial Memory Unit at Charing Cross Hospital recently sponsored a booth at New Scientist Live where they were able to speak to potential participants and others who could recommend friends or family. These types of non-clinical settings attract high footfall in engaged communities. Raising awareness of the challenge is just one way we can attract interest in participation. More than ever we need to embrace non-clinical settings that put us in the community.
Wide-scale education and support
Given that as many as three-quarters of adults have no idea how to get involved in medical research, awareness and education remain a constant challenge for recruitment. Targeting different populations (i.e., primary care doctors, residential homes inhabitants and staff, patient support groups, community centre members, and the general public) using multiple channels is essential.
This can be achieved through informative public campaigns that explain the urgency of combating the increasing prevalence of Alzheimer’s and the importance of research to succeed in this enormous challenge. Globally, there’s a need for people to understand risk to make informed decisions about their health, whether that’s making a change to their lifestyle or volunteering for a clinical trial. Alzheimer’s and other dementias begin with a long preclinical phase in which interventions are potentially more effective. With this in mind, it’s foreseeable that the number of people without symptoms who decide to enrol in Alzheimer’s research programs will grow.
Ongoing coordination with trial registries
Registries of people, including those who are cognitively normal and potentially willing to participate in research studies, are an invaluable source of participants for clinical trials. In the UK, Join Dementia Research is connecting researchers with people who want to participate in studies and has enrolled 10,593 volunteers to date.
Researchers need to be able to coordinate between multiple registries and a network of centres that are geographically close to potential participants to make research participation less burdensome. While people signing up to these registries won’t always be eligible for studies that require additional screening criteria, such as a gene variants or evidence of amyloid build-up, they still provide an option that could help facilitate recruitment for many other trials.
As always, the solution is not straightforward. However, when faced with new challenges, the ability to adapt processes and find new solutions is critical. Taking action on the ground and supporting industry, academic and non-profit organisations to advance Alzheimer’s research together will determine whether we are ultimately successful.