Abstract

Clinical trials are biomedical and behavioral research studies of human subjects designed to improve patient care and determine if new interventions are safer, more effective and lead to a better quality of life than existing standards of care. The participation of human subjects with intellectual and developmental disabilities (IDD) of any age in clinical trials and, by extension, clinical research faces many challenges, including research ethic concerns and lack of appropriate validated outcome measures. The participation of patients with IDD in clinical trials is important in order to improve care in this vulnerable population.

Keywords

Autism Spectrum Disorder Down Syndrome Intellectual Disability Minimal Risk Validate Outcome Measure 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Obstetric and Pediatric Pharmacology and Therapeutics BranchThe Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIHBethesdaUSA

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