Chronic Neuro-degenerative Disease: How To Make Clinical Trial Participation Accessible

Author: MRN

Clinical trial enrollment for chronic neurodegenerative diseases continues to remain low and slow with much higher costs than other trials in other therapeutic indications.1 Further, older patients from minority groups are even less likely to participate in studies – significantly reducing both the generalizability of the clinical trial and the understanding of the effectiveness and safety of the drug post-treatment.2,3

So how do we tackle this problem? A systematic review of multiple clinical trials in neurodegenerative diseases, including Alzheimer’s, Parkinson’s, Huntington’ and amyotrophic lateral sclerosis (ALS), found that a patient-centric trial design is one of three keyways to promote patient participation, along with better educational materials and strong HCP-patient-caregiver relationships.1

Putting patients and caregivers at the heart of clinical trial design and development will benefit stakeholders and patients alike. And it is far less complicated than many think it to be. Trial design can be considered ‘patient-centric’ when anything that will make it easier or simpler for a patient to participate in a trial is facilitated. This includes:

  • Reducing the overall workload for patients and their caregivers
  • Making participating more convenient
  • Reducing the invasive nature of the investigations
  • Consideration of the patient and caregiver’s requirements and lifestyle

These elements of a patient-centric trial can be achieved with solutions such as Home Trial Support, and community-based Site Networks.

Home Trial Support (HTS) is a particularly effective solution for patients with chronic neurodegenerative diseases. For those with Alzheimer’s/Dementia, familiar surroundings and routine are critical to their overall well-being and quality of life.4 HTS means that not only are these patients able to remain in their environment for the majority, if not all of the study, but a routine can be formed with the Home Healthcare Professional (HCP) – preventing needless distress that breaks in routine and unfamiliar surroundings can cause.

In 2008, an analysis across 108 study partners of patients with mild to severe Alzheimer’s found home visits had the strongest impact on willingness to consent, raising willingness from 17% to 27% of patients. When coupled with a low-risk trial and a higher probability of getting an active drug (rather than placebo), this rose to 60%. The worse the cognitive function of the patient, the stronger these correlations became.5

For those suffering from ALS, Parkinson’s and Huntington’s Disease, travel and related expenses for themselves and their caregivers can be a barrier to participation.6 HTS is again a solution that can help minimize this burden, but so are community-based sites. By using a site network, sponsors can effectively bring the trial to their patients, minimizing travel times and related costs. Further, as noted previously, strong ties with their local HCPs and clinical staff can be an influencing factor on a patient’s decision about trial participation. By working with local sites, patients are able to form those relationships with doctors they either already know, or view as members of their community.

MRN has effectively delivered over 23,000 in-home visits for patients with Alzheimer’s and has HTS capabilities in over 99 countries. Further, our Site Network continues to expand, with over 70 sites already active in communities across North America, UK, Europe and LATAM. Learn how our solutions can accelerate trial timelines by bringing your trial to more patients here.

References:

  1. Weemering D N, et al. Trial Participation in Neurodegenerative Diseases: Barriers and Facilitators: A Systematic Review and Meta-Analysis. Neurology. July 2024.
  2. Lau YH, et al. Does Ethnicity Influence Recruitment into Clinical Trials of Parkinson’s Disease? J Parkinsons Dis. Dec 202.
  3. Raman R, et al. Tackling a Major Deficiency of Diversity in Alzheimer’s Disease Therapeutic Trials: An CTAD Task Force Report. J Prev Alzheimers Dis. May 2022
  4. Karlawish J, et al. How redesigning AD clinical trials might increase study partners’ willingness to participate. Neurology. 2 Dec 2008.
  5. Alzheimer’s Project. The Importance of Routine and Familiarity to Persons with Dementia. June 2020. https://alzheimersproject.org/the-importance-of-routine-and-familiarity-to-persons-with-dementia/, Last Accessed 9 Dec 2024.
  6. Coull BM, et al. Frontiers of neurology and neuroscience. Clinical trials in the neurosciences. Front Neurol Neurosci. March 2009.
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