Clinical considerations for the inclusion of individuals with autism spectrum disorder in clinical trials

Diagnoses of autism spectrum disorder (ASD) have increased considerably over the past 20 years. Because of this rise and the inherent complexity of ASD, there is a need for an increased number of scientifically valid basic and clinical research studies addressing this disorder. This manuscript serve...

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Bibliographic Details
Published in:Progress in neuro-psychopharmacology & biological psychiatry 2019-03, Vol.89, p.295-302
Main Authors: Urbano, Maria R., Teal Raffaele, C., Kreiser, Nicole L., Flaherty, Jennifer M., Hartmann, Kathrin
Format: Article
Language:English
Subjects:
Autism spectrum disorder
Clinical research
Clinical trials
DSM5 diagnosis
Translational
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Summary:Diagnoses of autism spectrum disorder (ASD) have increased considerably over the past 20 years. Because of this rise and the inherent complexity of ASD, there is a need for an increased number of scientifically valid basic and clinical research studies addressing this disorder. This manuscript serves as an introduction to the clinical presentation of ASD as well as the unique challenges and modifications required to conduct clinical research with this population. This includes detailing the current diagnostic criteria, process of receiving an ASD diagnosis, information on assessment measures, and special considerations when developing research. It is the hope that this information will provide researchers interested in conducting clinical trials with those with ASD with baseline information and considerations when developing their research topics and methodology. •Research with Autism Spectrum Disorder (ASD) requires special consideration.•There are major differences between DSM-IV and DSM5 diagnoses.•Specific diagnostic, clinical, and research assessment measures are used.•Co-morbidities are common in ASD and may impact research.•Research procedures may involve modification due to ASD traits.
ISSN:0278-5846
1878-4216
DOI:10.1016/j.pnpbp.2018.09.013