Health Care for People with Intellectual and Developmental Disabilities across the Lifespan pp 2225-2231 | Cite as
Clinical Trials
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 MeasureReferences
- 1.Emanuel EJ. Ethical and regulatory aspects of clinical research: readings and commentary. Baltimore: Johns Hopkins University Press; 2003. xxxv.Google Scholar
- 2.Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274(24):1354–60.CrossRefPubMedGoogle Scholar
- 3.Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA. 1996;276(1):67–72.CrossRefPubMedGoogle Scholar
- 4.McDonald KE. “We want respect”: adults with intellectual and developmental disabilities address respect in research. Am J Intellect Dev Disabil. 2012;117(4):263–74.CrossRefPubMedGoogle Scholar
- 5.Schwenzer KJ. Protecting vulnerable subjects in clinical research: children, pregnant women, prisoners, and employees. Respir Care. 2008;53(10):1342–9.PubMedGoogle Scholar
- 6.Lennox N, Taylor M, Rey-Conde T, Bain C, Purdie DM, Boyle F. Beating the barriers: recruitment of people with intellectual disability to participate in research. J Intellect Disabil Res. 2005;49(Pt 4):296–305.CrossRefPubMedGoogle Scholar
- 7.Iacono T. Ethical challenges and complexities of including people with intellectual disability as participants in research. J Intellect Dev Disabil. 2006;31(3):173–9.CrossRefPubMedGoogle Scholar
- 8.Dresser R. Research oversight and adults with cognitive impairment. Hastings Center Rep. 2003;33(6):9–10.CrossRefGoogle Scholar
- 9.Carlson L. Research ethics and intellectual disability: broadening the debates. Yale J Biol Med. 2013;86(3):303–14.PubMedPubMedCentralGoogle Scholar
- 10.Lotan M, Moe-Nilssen R, Ljunggren AE, Strand LI. Measurement properties of the Non-communicating Adult Pain Checklist (NCAPC): a pain scale for adults with intellectual and developmental disabilities, scored in a clinical setting. Res Dev Disabil. 2010;31(2):367–75.CrossRefPubMedGoogle Scholar
- 11.Navas P, Verdugo MA, Arias B, Gomez LE. Development of an instrument for diagnosing significant limitations in adaptive behavior in early childhood. Res Dev Disabil. 2012;33(5):1551–9.CrossRefPubMedGoogle Scholar
- 12.Feldman MA, Bosett J, Collet C, Burnham-Riosa P. Where are persons with intellectual disabilities in medical research? A survey of published clinical trials. J Intellect Disabil Res. 2013; Epub ahead of print.Google Scholar
- 13.Cleaver S, Ouellette-Kuntz H, Sakar A. Participation in intellectual disability research: a review of 20 years of studies. J Intellect Disabil Res. 2010;54(3):187–93.CrossRefPubMedGoogle Scholar
- 14.Law J, Garrett Z, Nye C. The efficacy of treatment for children with developmental speech and language delay/disorder: a meta-analysis. J Speech Lang Hear Res. 2004;47(4):924–43.CrossRefPubMedGoogle Scholar
- 15.McIntyre LL. Parent training for young children with developmental disabilities: randomized controlled trial. Am J Ment Retard. 2008;113(5):356–68.CrossRefPubMedPubMedCentralGoogle Scholar
- 16.Scahill L, Dimitropoulos A, McDougle CJ, Aman MG, Feurer ID, McCracken JT, et al. Children’s Yale-Brown obsessive compulsive scale in autism spectrum disorder: component structure and correlates of symptom checklist. J Am Acad Child Adolesc Psychiatry. 2014;53(1):97–107.CrossRefPubMedGoogle Scholar
- 17.Rickards AL, Walstab JE, Wright-Rossi RA, Simpson J, Reddihough DS. A randomized, controlled trial of a home-based intervention program for children with autism and developmental delay. J Dev Behav Pediatr. 2007;28(4):308–16.CrossRefPubMedGoogle Scholar
- 18.Kent JM, Hough D, Singh J, Karcher K, Pandina G. An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder. J Child Adolesc Psychopharmacol. 2013;23(10):676–86.CrossRefPubMedPubMedCentralGoogle Scholar
- 19.Fernell E, Hedvall A, Westerlund J, Hoglund Carlsson L, Eriksson M, Barnevik Olsson M, et al. Early intervention in 208 Swedish preschoolers with autism spectrum disorder. A prospective naturalistic study. Res Dev Disabil. 2011;32(6):2092–101.CrossRefPubMedGoogle Scholar
- 20.Baribeau DA, Anagnostou E. Social communication is an emerging target for pharmacotherapy in autism spectrum disorder. A review of the literature on potential agents. J Can Acad Child Adolesc Psychiatry. 2014;23(1):20–30.PubMedPubMedCentralGoogle Scholar
- 21.Wheeler A, Raspa M, Bann C, Bishop E, Hessl D, Sacco P, et al. Anxiety, attention problems, hyperactivity, and the aberrant behavior checklist in fragile X syndrome. Am J Medl Genet Part A. 2014;164A(1):141–55.CrossRefGoogle Scholar
- 22.van Trotsenburg AS, Vulsma T, van Rozenburg-Marres SL, van Baar AL, Ridder JC, Heymans HS, et al. The effect of thyroxine treatment started in the neonatal period on development and growth of two-year-old Down syndrome children: a randomized clinical trial. J Clin Endocrinol Metabol. 2005;90(6):3304–11.CrossRefGoogle Scholar
- 23.Peruzzolo TL, Tramontina S, Rohde LA, Zeni CP. Pharmacotherapy of bipolar disorder in children and adolescents: an update. Rev Bras Psiquiatr. 2013;35(4):393–405.CrossRefPubMedGoogle Scholar
- 24.Dunn AG, Mandl KD, Coiera E, Bourgeois FT. The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children. PLoS One. 2013;8(12):e84951.CrossRefPubMedPubMedCentralGoogle Scholar
- 25.Nikles CJ, McKinlay L, Mitchell GK, Carmont SA, Senior HE, Waugh MC, et al. Aggregated n-of-1 trials of central nervous system stimulants versus placebo for paediatric traumatic brain injury–a pilot study. Trials. 2014;15:54.CrossRefPubMedPubMedCentralGoogle Scholar
- 26.Kolobe TH, Christy JB, Gannotti ME, Heathcock JC, Damiano DL, Taub E, et al. Research summit III proceedings on dosing in children with an injured brain or cerebral palsy. Phys Ther. 2014; Epub ahead of print.Google Scholar
- 27.Cameron EC, Maehle V, Reid J. The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Pediatr Phys Ther. 2005;17(2):107–19.CrossRefPubMedGoogle Scholar
- 28.Lichter-Konecki U, Nadkarni V, Moudgil A, Cook N, Poeschl J, Meyer MT, et al. Feasibility of adjunct therapeutic hypothermia treatment for hyperammonemia and encephalopathy due to urea cycle disorders and organic acidemias. Mol Genet Metab. 2013;109(4):354–9.CrossRefPubMedGoogle Scholar