DEI Special Edition Spring / Summer 2024
Why is Autism an Unspoken Exclusion Criterion in Clinical Trials ?
By Daniel J. Fox, MPH, PhD
A CRO recently learned of my commitment to serving our autistic community and asked me to help them recruit autistic patients for a new trial:
“ Of course! Anything for our community. What did you have in mind? ” “ We were hoping you would reach out to your autistic community and physi- cians to refer participants to our active clinical research sites. ” “ I ’ m sorry – that won ’ t work with the autistic community. We would need the visits to be performed in a familiar environment to accommodate their autistic needs. ” “ It ’ s far too late in the process to make changes like that! Are you sure you can ’ t just refer them to our sites? ” I declined the opportunity. There was no way an inconsiderate strategy like that would work for an autistic patient population. What ’ s more, the same organization who was managing the trial was not willing to consider the needs of the same patients they were trying to enroll. Unfortunately – this scenario is not isolated. Autistic patients are almost al- ways alienated from clinical trial participation not because they, as autistic individuals, are excluded from an IRB - approved protocol, but rather because we as an industry exclude them when we do not accommodate their needs. “ Please Don ’ t Take My Structure ” Perform a quick Google search: “ Autism Spectrum Disorder (ASD) requires structure, ” and let the results speak for themselves. Consistency and routine are not just a luxury for autistic patient populations – they are a necessary and well - documented lifestyle requirement. It can take years to develop this consistent relationship for an autistic individ- ual. At times, caretakers and occupational therapists admit it is a good day when an autistic patient successfully takes a single step into a physician ’ s hallway. The next day, another step … and another. Years later, that autistic patient may finally trust the environment enough to accept care in the exam room. We have witnessed dedicated physicians and dentists set up in a
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