Public interest in participation in clinical trials for dementia is growing as governments become more vocal about the need to find treatments. A number of well-known organizations have well-established processes for linking patients with clinical trials. Alzheimer’s Association’s Trialmatch in the US and the United Kingdom’s Clinical Research Network (UKCRN) Study Portfolio allow patients to search for trials that they would like to participate in. In the case of dementia however, the disease may hinder a person’s ability to search for trials, potentially limiting access to experimental treatments. As research focuses more on prevention of Alzheimer’s it is important to include people interested in research who have no symptoms of memory loss.
As the industry moves towards targeting dementia earlier we foresee the need for trials with larger numbers of participants. There has therefore been an increasing need to focus on establishing registries of interested participants prior to the onset of dementia. Those who sign up indicate the kinds of research that they are keen to participate in and receive relevant information about research opportunities and new findings. There are a number of good examples globally, such as the Alzheimer’s Prevention Initiative in the US. One step beyond registries are cohorts of people who have been characterized in terms of demographics, cognitive performance or biological samples. Examples include the FINRISK cohort in Finland and the UK Dementia Research Platform (UKDP). The UKDP, launched in April this year, is a public-private partnership that will follow as many as two million people over time. The database was explicitly created to form a foundation for future experimental medicine studies aimed at early detection, treatment and ultimately, prevention of dementias.
With the growth of these registries and cohorts, a platform to combine these groups into network of trial registries across the world is needed. In the past year both the New York Academy of Sciences and the European Innovative Medicines Initiative (IMI) have called for the establishment of multinational trial-ready registries to accelerate trial recruitment.
The benefits of such a ‘meta-registry’ are clear and include accelerated recruitment, reduction of expense and time to conduct AD trials. Those planning clinical trials could search the global registry for subjects who fit protocol criteria and who have given consent to be contacted about research. Rapid and accurate feasibility data from these databases alone would be invaluable in planning future trials.
There are, however, numerous challenges to be overcome in developing a global network of registries. Striking a balance between safeguarding privacy and linking interested participants to relevant research remains challenging. Trust in the use of personal data is fundamental to public participation. As risk biomarkers are developed, protocols around risk counselling and impact on a person’s private life will need to be incorporated to maintain registry participation.
Funding international registry networks is another challenge and novel funding mechanisms are likely to play an increasing role. Database infrastructure and public engagement through advertising, primary care settings and social media will have a cost. Industry and state funding has been predominant historically but the global scale means that social impact investing may best be applied to the development of a clinical trial infrastructure. With increasing funds from venture philanthropy, what we may see is a demand for a wider focus in clinical trials to address improved care delivery, non-cognitive symptom management and care outcomes.
With the growth of trial registries we are likely to see the emergence of fewer sites with large trial cohorts. Those with registries developed in a way that allows industry to interrogate the cohort against the inclusion criteria for a specific trial rapidly and accurately will increasingly become the first choice for clinical trials. In addition to the promise of rapid recruitment, the use of a few large sites will allow for more consistent trial data.
As the trend towards large registries and global networks continues there is perhaps much that we can learn from trials that are often the opposite in terms of scale. Successful programs for the treatment of rare disorders have been achieved through close partnerships with affected communities and interested stakeholders. Patient engagement is high and few expert sites tend to contribute the majority of participants.
For advice on using trial registries for faster trials or to speak to a Covance representative, please contact us.