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

Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:295-302. doi: 10.1016/j.pnpbp.2018.09.013. Epub 2018 Oct 2.


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.

Keywords: Autism spectrum disorder; Clinical research; Clinical trials; DSM5 diagnosis; Translational.

Publication types

  • Review

MeSH terms

  • Autism Spectrum Disorder / diagnosis*
  • Autism Spectrum Disorder / epidemiology
  • Clinical Trials as Topic / methods*
  • Humans
  • Patient Selection*