The global demographic is undergoing a significant shift, with an increasing number of elderly patients. This aging population brings a host of health challenges, many of which result in disabilities that profoundly affect quality of life, especially when including elderly patients in clinical trials. Richie Kahn’s recent article on the importance of inclusivity in clinical trials, especially for those with disabilities, serves as a timely reminder of the gaps in our current medical research landscape. But it’s also important to consider designing better clinical trials for elderly with disabilities. This article will discuss these topics.

Richie Kahn’s Insightful Perspective on Disabled Patients in Clinical Trials:

Kahn’s article provides a comprehensive look into the disparities in healthcare accessibility for adults with disabilities across different countries. He emphasizes that those with disabilities are four times more likely to report unmet healthcare needs, a statistic that is both alarming and revealing. Kahn’s perspective is deeply personal, as he himself is a clinical trialist with a rare disease (Wolfram syndrome) that leads to both blindness and sensorineural hearing loss. Drawing from this personal experience, as well as the United Nations’ definition of disabilities, Kahn categorizes disabilities into various segments. He not only highlights the unique challenges each group faces when participating in clinical trials but also underscores the importance of thoughtful consideration in designing these trials. For instance, he presents a case example of a trial designed for patients with severe vision loss, emphasizing the myriad of considerations that might not be immediately apparent to those unfamiliar with the disability.

A Broader Perspective on Aging and Disabilities in the U.S.

In the United States, the burden of disability among the aging population is evident. Disabilities, including cognitive and physical, pose significant challenges1. Mild cognitive impairment, a precursor to Alzheimer’s disease, is a growing area of concern, with sensory integration training emerging as a potential intervention to improve mental mobility in affected elderly individuals2. Additionally, sensory impairments, particularly in vision and hearing, are prevalent and can significantly impact the quality of life and societal participation of the elderly3. Furthermore, mental health conditions, especially depression, can be debilitating, affecting cognitive functions and social interactions3.

Recommendations for Study and Protocol Design for Inclusivity in Clinical Trials:

  1. Holistic Patient Assessment: Beyond the specific condition being studied, a comprehensive health assessment of elderly participants can provide insights into co-existing conditions and disabilities.
  2. Flexible Trial Protocols: Recognize that elderly patients might have multiple health issues. Design trials that can accommodate variations in health profiles.
  3. Accessibility and Comfort: Ensure study sites are easily accessible, with provisions for those with mobility issues. Consider the comfort of participants, especially when designing study visits, to not put the patients through too many procedures. Focus on attaining the study’s endpoints instead.
  4. Clear Communication: Use simple language, visual aids, and repetition to ensure that elderly participants fully understand the trial procedures and their roles. Also use eConsent and include rich media, like videos, to easily explain the study to the participants.
  5. Engage Caregivers: Often, elderly individuals rely on caregivers. Engaging them in the trial process can provide additional support to participants.

Summary

The increasing prevalence of age-related disabilities in the U.S. necessitates a shift in how clinical trials are designed and conducted. Richie Kahn’s article is a stepping stone, urging us to think deeper and act more inclusively. As we design clinical trials for elderly with disabilities, let’s ensure they truly represent the diverse and complex needs of our aging population.

References:

  1. Common Physical Health Issues in Persons with Intellectual Disability
  2. Influence of sensory integration training on mental mobility of elderly people with MCI
  3. Prevalence of sensory impairments, physical and intellectual disabilities, and mental health in children and young people with self/proxy-reported autism: Observational study of a whole country population