Unlocking neurodivergent participation: Nine ways to create patient-centric clinical trials

The medical research community has historically struggled to adequately represent neurodivergent populations in clinical trials. This systemic challenge creates a dual concern: research findings may lack transferability across varied populations while simultaneously limiting access to potentially beneficial treatments for neurodivergent individuals. The implications extend beyond scientific validity—they directly impact patient outcomes.

Individual neurodivergent preferences don’t fit into neat and obvious needs. How do these individuals react to new environments? Do they need quiet spaces to help minimize over-stimulation? Do staff need specific training to spot and accommodate stimming? Do protocols need to differentiate between distressed behaviors and reactions to the investigational product (IP)? Do materials need to be made available in different formats to accommodate those individuals who struggle with blocks of text?

At Fortrea, we're dedicated to transforming this landscape by championing approaches that empower neurodivergent participants to fully engage in clinical research. We’ve drawn on our extensive experience and partnerships to provide some of our top recommendations around patient-centered methodologies.

Nine tips for designing trials for neurodiverse and autistic individuals

1. Understand your patients’ experiences 
Early engagement in understanding the patient’s perspective has long been important, but taking time to understanding neurodivergent patient experience significantly reduces downstream challenges and creates a foundation for meaningful participation. Their needs are often outside the comprehension of those who are not impacted in this way, meaning that without this critical groundwork, trials risk encountering avoidable complications that impact both participant experience and research outcomes:

• Be open minded and gather comprehensive patient insights: It is important to establish dedicated channels for consulting with neurodivergent individuals about their unique perspectives and preferences before finalizing protocols. Consider multiple feedback methods, including interviews, surveys, and advisory panels that accommodate different communication styles.
• Incorporate feedback throughout from the start: Integrate patient insights into trial protocols, informed consent forms (ICFs), and educational materials to create patient-centric trial designs that reduce barriers to participation

2. Accommodate communication needs 
Clear and accessible communications are essential for neurodiverse patients:

• Create accessible materials: Ensure trial materials are intuitive, easy to understand, and free of unnecessary jargon. Providing information in various formats (e.g., written, audio, video) accommodates different learning styles and preferences
• Adapt for specific needs: For some neurodiverse conditions, such as dyslexia, carefully consider style, font, and sentence construction. Some examples include avoiding block capitals or underlining, using supportive imagery, and enabling adjustable digital contrast
• Balance information sharing: Recognize the importance of providing sufficient preparation time through pre-reads, while being mindful not to overwhelm participants with excessive information
• Use visual supports: Explanatory videos demonstrating what to expect at each appointment can be watched repeatedly or at the right times for autistic individuals to assimilate the information

3. Keep your scheduling flexible, but your support structured 
Predictability and flexibility work together to create a supportive environment:

• Accommodate varying needs: Consider whether a flexible schedule option can be built into the trial, which works with participants established routines and energy levels
• Reimbursement for sensory preferences: Ensure provision of sufficient reimbursement that accounts for the preferred routines and travel needs of neurodivergent participants. For example, taking a taxi rather than a bus may be less anxiety inducing, and having the same taxi driver each time will provide the patient with reassurance, routine, and confidence. A concierge service could also be considered
• Provide timing assurances: Many people with autism will worry about timings – things like busy queues in reception areas, times of appointments changing, what happens if there is a delay, etc. Support them with transparent communication at the site

4. Create sensory-friendly environments 
Physical spaces can significantly impact participant comfort and effectiveness:

• Prioritize first impressions: Busy clinics can be very overwhelming – the first visit is critical to the success of future visits. Let patients know that they have the option to bring comfort items from home to make the experience feel less out of the ordinary and help put them at ease
• Minimize sensory overload: Thoughtfully designed trial sites with quiet rooms, adjustable lighting, and controlled noise levels will create a more accessible environment for neurodivergent people to participate in trials. Also ensure spaces aren't overly hot or stuffy, as this can increase discomfort and anxiety
• Build in decompression time: Provide options for participants to take breaks and self-regulate as needed after time spent socializing or intense periods of interactions

5. Provide comprehensive staff training 
Prioritize research centers with established neurodivergent expertise as your foundation for success. For less experienced sites, implement targeted training programs to equip all clinical staff with specialized training to understand and address sensory sensitivities and communication preferences:

• Honor communication styles: Ask directly: "Would you prefer I speak with you or your supporter? Would you like to answer questions yourself?" Be aware of different ways participants may assimilate information, an inability to speak in the moment, for whatever reason (anxiety being one), does not indicate an inability to understand
• Recognize anxiety signals: Be prepared for a range of anxiety expressions that vary by individual and respond with appropriate accommodations
• Prioritize patience and preparation: Proactively provide additional time for visits. Allow participants to work through their prepared questions without rushing, even when presented with extensive lists
• Maintain predictability: Avoid unexpected procedures or assessments that participants haven't mentally prepared for and provide adequate processing time following difficult news. Give time to let them absorb bad news and settle before having them leave the room

6. Tailor consent processes 
While working within regulatory constraints, can simplified pre-reads or videos be created to support the consent discussion?

• Simplify without compromising: Create consent information in various mediums, including video explanations and in-person discussions. Ensure participants have ample time to review, question, and understand consent materials before making decisions
• Provide tangible tools: Offer printed consent forms (rather than just digital screens) along with highlighters or pens to make information more digestible, and provide note pages or materials for them to write out their thoughts

7. Involve caregivers and support networks 
Supportive relationships enhance the trial experience and help support neurodivergent individuals as they process information, communicate, and experience the trial process:

• Welcome support persons: Encourage caregivers or trusted support individuals to participate in the trial process when desired by the participant
• Provide resource training: Consider providing caregivers specialized training and resources to effectively support participants throughout the trial journey

8. Provide ongoing support 
Continuous support and engagement throughout the trial, including mental health resources, ensures lasting participation:

• Reduce cognitive load: Digital tools like apps or SMS reminders help participants remember appointments and manage trial requirements
• Conduct regular check-ins: Scheduled touchpoints address concerns or challenges before they impact participation. They also help to manage transitions effectively, making the time to formally introduce new study team members with clear explanations of their roles
• Accommodate scheduling challenges: Be ready to rebook appointments if the individual simply cannot accommodate the visit on a certain date or the visit must be cut short
• Provide session summaries: Give participants a concluding summary of each visit (e.g., "today you had a blood draw and discussed medication changes") which will help to prompt questions and build an exchange of information

9. Gather feedback and continuously improve 
Ongoing refinement drives excellence to continuously improve both the current and future trials:

• Collect structured feedback: Gather input from neurodivergent participants about their experiences at key touchpoints in the trial, and ensure this feedback is collected in a way which is accessible and comfortable to that individual
• Remain adaptable: Where possible be open to adjusting current and future trials based on participant feedback, to maximize representation in the patient population
• Expect a reaction: Anticipate varied responses – and not always the one you are expecting; build constructively on positive and negative feedback

Accommodating neurodivergent individuals in clinical trials requires a fundamental shift in approach—moving from an afterthought to accessibility as a foundation. This transformation demands strategic vision, specialized expertise, and genuine collaboration with neurodivergent communities.

These are just a few of the ways that we, at Fortrea, are helping transform clinical trials into accessible environments for neurodivergent individuals that honor the unique perspectives and needs of every participant. We are dedicated to enhancing the experience for all individuals engaging in clinical research through our deep expertise and offerings, such as Fortrea Patient Advocate Council, created to understand patients’ unique perspectives. This commitment reflects our broader mission to advance healthcare through innovation and partnership.

LEARN MORE about Fortrea's commitment to patient centricity in trial design or our patient-centric approaches for autism studies.

Contact our specialized team today to find out how we can help