Parexel

Stacy Hurt

Inclusive Research Strategist

Stacy Hurt is Chief Patient Officer at Parexel, where she leads efforts to embed patient perspectives into drug development and healthcare solutions from the earliest stages. Stacy is also a Non-Executive Adviser for Inventus.

What Trial Diversity Still Gets Wrong

For years, clinical research has worked to improve trial diversity. Sponsors, CROs, regulators, and advocacy organizations have invested in expanding participation among historically underrepresented populations. This commitment is necessary and overdue. Yet one of the world’s largest and most medically affected populations remains too often absent from the conversation: people with disabilities.

More than one billion people globally live with some form of disability. Many also experience chronic disease, barriers to care, and health disparities. If trials are intended to reflect the people who will ultimately use new therapies, accessibility must be treated as a core element of diversity - not as a separate initiative or a last-minute accommodation.

As an advocate for patients, and a mother with a disabled younger son—Emmett was diagnosed with a chromosome disorder at 8 months of age—I am acutely aware of the issues which need to be tackled.

Patients with disabilities have told me about the lack of assistive technology in ICF’s and other required paperwork, and the lack of accessibility either en route to the appointment (meaning no way to even get there) or within the appointment itself. 

With Emmett, I’m astounded at the lack of exam tables that lower to lift him onto them and the lack of wheelchair scales to get a weight. And how are we supposed to get his height when he is unable to stand? Already from the beginning, we have inaccurate data because of lack of accessible equipment for data capture. 

Digital Trials that Work for Everyone

Accessibility extends far beyond ramps, elevators, and entrances. It affects every stage of the participant journey: learning about a study, understanding consent, enrolling, attending visits, using technology, completing assessments, and remaining engaged through completion. A visually impaired participant may be unable to use a questionnaire that is incompatible with a screen reader. Someone with hearing loss may need captioning, while a person with cognitive differences may struggle with dense consent language.

People living with mobility limitations, chronic pain, or fatigue may find frequent travel and lengthy appointments unsustainable. These barriers are rarely intentional, but they often remain invisible until a patient encounters them. Accessibility must therefore shift from an accommodation mindset to “Accessibility by Design”: asking from the beginning how to make a study workable for the widest possible range of participants.

This begins during protocol development. Eligibility criteria should be reviewed for exclusions that are not scientifically necessary and may disproportionately affect people with disabilities. Procedures and visit schedules should be assessed for physical, cognitive, sensory, financial, and logistical burden. Consent forms and study materials should use plain language and accessible formats. Sites should be evaluated not only for regulatory compliance, but also for parking, transportation, navigation, communication, caregiver support, and flexible scheduling.

Technology can help when it is intentionally designed and tested with disabled users. Accessible electronic consent can offer adjustable text, audio, captioning, clear navigation, and additional review time. Telehealth and hybrid models can reduce travel and fatigue. Remote data collection, electronic clinical outcome assessments, wearables, connected devices, reminders, and secure communication can make participation more flexible and support continued engagement.

Artificial intelligence may identify confusing language, flag procedures that create disproportionate burden, and reveal patterns of exclusion or dropout. Yet technology is not automatically inclusive. A virtual visit is inaccessible if the platform cannot work with assistive technology; a wearable is unhelpful if it is difficult to fasten, read, charge, or operate. Automated tools can also reproduce bias when people with disabilities are absent from design, testing, or training data.

Every patient-facing solution should be assessed against recognized accessibility standards, validated with diverse users, supported by nondigital alternatives, and monitored after deployment. Technology should expand participants’ choices, not become another condition of participation. The most reliable way to identify barriers is to involve patients and caregivers early and often: in protocol review, platform testing, communications, and the definition of meaningful accessibility measures.

Moving Accessibility from Intention to Accountability

My lived experience means I bring my lens of empathy into trial design. I look at every trial as if Emmett, who is now 21, were participating in it. For example, due to Emmett’s flapping/clapping as a result of his autism, I worry about how he would do multiple blood draws. He would probably need a port implanted. And I would hope that telehealth appointments could substitute for multiple visits to sites, since it is so labor-intensive to lift Emmett into his wheelchair each time and transport him. Emmett has no understanding of fasting or waiting, so it would be vitally necessary for visits to be on time and efficient. “Typical” burdens of participating in clinical trials are magnified ten times for those with disabilities.

Designing with patients, rather than for them, often produces studies that are clearer and easier for everyone to navigate.

I am currently a non-executive advisor for Inventus, a UK-based company and industry leader. Inventus is the only company dedicated to creating purpose-built patient and site devices exclusively for clinical trials. They are designed around the patient journey, not the constraints of infrastructure.

I intend to challenge the status quo and move these principles from intention to accountability. By bringing in my patient and caregiver perspective into early program development with sponsors, I will ask whether accessibility was considered before trial strategies were approved. Patients With Disabilities (PWDs) should have the option of a pre-appointment questionnaire as a needs assessment to set them up for success in trial participation. 

I want to encourage leaders to embed accessibility in governance, risk, quality, technology procurement, vendor expectations, and performance measures. Questions such as, “who may be excluded by this decision” and “was the technology tested with the people expected to use it?” are best asked by someone who has walked in these shoes. Technology could also be used to identify these needs much further upstream in the recruitment/enrolment process.

The future of inclusive research will not be defined only by who is invited into a trial, but by whether people can genuinely access, understand, and complete it. Accessibility is not a special initiative. It is a prerequisite for equitable clinical research and a practical pathway to better participation, better data, and better decisions.