Thoughtful Consideration of Disabilities in Clinical Trials
Richie Kahn
Canary Advisors
T

he prevalence of adults living with disabilities varies widely from country to country. In Malta, 11% of the population has one or more disabilities. In Latvia, the figure is closer to 40%. Across the European Union (EU), an average of 24% are living with disabilities, and the proportion of those with disabilities only increases over time. Those living with disabilities are four times more likely to report that their healthcare needs are unmet, which may well lead them to pursuing clinical research as a care option.

Over the past few years, there’s been an increasing focus on clinical trial accessibility. After all, clinical trials are designed to be representative of the broader population, so it only makes sense to try to include as diverse a sample as possible. Still, there’s plenty of opportunity for thoughtful consideration of the needs of those with disabilities in order to ensure clinical trials are accessible for all.

Of course, awareness of disabilities is just the first step in designing clinical trials that are accessible to patients, irrespective of the particulars of the conditions they’re experiencing.

The United Nations (UN) Convention on the Rights of Persons with Disabilities defines persons with disabilities as individuals “who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others.” Practically speaking, this means people living with one or more limitations impacting visual processing, how they take in and/or process audio, cognition, communication, physical abilities, or their emotional state. As a patient engagement expert and clinical trialist with a rare disease (Wolfram syndrome) that leads to both blindness as well as sensorineural hearing loss, making clinical trials more accessible to this diverse and highly consequential population is a topic very near and dear to my heart.

A Case Example

Imagine your team is designing a trial for a patient population impacted by severe vision loss. There are some barriers to participation that might be more obvious than others. For example, the patients in your study may be too visually impaired to drive, so transportation challenges will need to be worked out. But there are a number of other considerations that wouldn’t necessarily occur to individuals who aren’t personally dealing with vision loss.

Some sponsors might organize a patient advisory board prior to protocol design to learn more about patient preferences, unmet needs, and quality-of-life impacts of this severe form of vision loss. This time spent with patients is also a perfect opportunity to explore:

  • Endpoints of interest
  • The burdens patients are willing to accept in order to participate in a trial that could potentially restore some of their vision
  • Concerns around clinical trial participation

To go the extra mile, consider diving in at a more granular level. For example, when a study coordinator is calling to set up the first clinical trial visit and explaining what’s expected of patients, they might want to address the logistics of traveling to and navigating the study site.

Topics to explore include:

  • Transportation
    • Does the patient drive or have access to reliable transportation? If lack of transportation is a theme across patients, perhaps the sponsor would be willing to book a taxi service?
    • Some patients might be interested to know that there’s a bus route that picks up and drops off two blocks away from the clinical trial site.
      • As a reminder, our hypothetical patient population is visually impaired. Don’t just get them to the front of the building. Ask if they need help getting to the clinic or navigating the halls of a vast academic medical center.
  • Accessibility
    • As patients are planning their visit, you might let them know that the side door (which is closest to the clinic and where a taxi would pull up) is not accessible to people with physical disabilities.
    • The front entrance, on the other hand, has a curb cut out and automatic door. Though farther away, it is easier to navigate for those with low vision.
  • The informed consent process
    • Do patients require any accommodations?
      • For example, eReaders and other pieces of accessibility technology can help visually impaired users zoom in and out, adjust contrast, or convert text to speech.

Patient-Focused Drug Development (PFDD)

For years, the vast majority of clinical trials have failed to meet timelines, and patient recruitment has been the most significant source of delay. Naturally, work intended to mitigate delay by better aligning clinical development programs with patient wants and needs is not new.

In 2012, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research created the patient-focused drug development (PFDD) framework, a systematic methodology by which key stakeholders learn about patient preferences, needs, and quality-of-life impacts from the patients themselves.

In 2021, an International Classification of Functioning, Disability and Health (ICF) reflection paper was submitted to the European Medicines Agency (EMA) which outlined proposed guidelines designed to bolster the PFDD framework. While there’s been tremendous progress and knowledge gleaned, there’s also plenty of room to incorporate consideration of disabilities into the clinical development process.

Richie Kahn is a public health professional by training, clinical researcher by trade, and patient advocate by necessity. He is co-founder & principal at Canary Advisors, a patient engagement firm that partners with organizations looking to better align their clinical development programs with patient wants and needs.
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