Conducting clinical trials in persons with Down syndrome : summary from the NIH INCLUDE Down syndrome clinical trials readiness working group
Baumer, Nicole (Boston Children's Hospital (Boston, Estats Units d'Amèrica))
Becker, Mara L. (Duke University School of Medicine)
Capone, George (The Johns Hopkins School of Medicine)
Egan, Kathleen (Parent/Advocate, Virginia, USA)
Fortea, Juan (Institut d'Investigació Biomèdica Sant Pau)
Handen, Benjamin L. (University of Pittsburgh)
Head, Elizabeth (University of California)
Hendrix, James E. (LuMind IDSC Foundation, Burlington, USA)
Litovsky, Ruth Y. (University of Wisconsin)
Strydom, Andre (King's College London)
Tapia, Ignacio E. (University of Pennsylvania)
Rafii, Michael S. (University of Southern California)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	The recent National Institute of Health (NIH) INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) initiative has bolstered capacity for the current increase in clinical trials involving individuals with Down syndrome (DS). This new NIH funding mechanism offers new opportunities to expand and develop novel approaches in engaging and effectively enrolling a broader representation of clinical trials participants addressing current medical issues faced by individuals with DS. To address this opportunity, the NIH assembled leading clinicians, scientists, and representatives of advocacy groups to review existing methods and to identify those areas where new approaches are needed to engage and prepare DS populations for participation in clinical trial research. This paper summarizes the results of the Clinical Trial Readiness Working Group that was part of the INCLUDE Project Workshop: Planning a Virtual Down Syndrome Cohort Across the Lifespan Workshop held virtually September 23 and 24, 2019.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Subject:	Down syndrome ; Intellectual disability ; Clinical trials ; Clinical research ; Research engagement ; Recruitment
Published in:	Journal of Neurodevelopmental Disorders, Vol. 14 (march 2022) , ISSN 1866-1955

DOI: 10.1186/s11689-022-09435-z
PMID: 35321660

9 p, 938.4 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles