Open AccessConcise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments
Author(s) -
Hake Ann M.,
Dacks Penny A.,
Arnerić Stephen P.
Publication year - 2017
Publication title -
alzheimer's and dementia: translational research and clinical interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.49
H-Index - 30
ISSN - 2352-8737
DOI - 10.1016/j.trci.2017.08.003
Subject(s) - general partnership , data sharing , informed consent , dementia , biobank , disease , relevance (law) , internet privacy , key (lock) , data access , clinical trial , psychology , medicine , public relations , business , political science , computer science , alternative medicine , computer security , bioinformatics , pathology , law , biology , programming language , finance
Informed consent forms that restrict the distribution of data and samples have been an impediment to advancing Alzheimer's disease (AD) understandings and treatments. The Coalition Against Major Disease public‐private partnership developed concise addenda to responsibly broaden data access of informed consent forms. Methods Coalition Against Major Disease members identified key elements for ensuring data and biospecimen access, and patient privacy protection according to applicable US law. Collaboration with the Alzheimer's Association established the understandability and relevance of the addenda with AD patients and Care Partners. Results Two key findings are (1) patients with dementia and Care Partners were shocked that their data and samples are not broadly shared and (2) with diverse feedback, two concise addenda were created to enable data and sample sharing both within and outside future sponsored studies (see Boxes). Discussion Increasing the access of valuable anonymized patient‐level clinical trial data has the potential to inform the foundational and regulatory science required to deliver innovative treatments for AD.