Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments

CAMD ICF working group

Research output: Contribution to journalShort survey

3 Scopus citations

Abstract

Introduction 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.

Original languageEnglish (US)
Pages (from-to)536-541
Number of pages6
JournalAlzheimer's and Dementia: Translational Research and Clinical Interventions
Volume3
Issue number4
DOIs
StatePublished - Nov 2017

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Keywords

  • Alzheimer disease
  • Biospecimen
  • Consortia
  • Data sharing
  • Databases
  • Drug development tools
  • Informed consent
  • Regulatory sciences

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health

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