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

2 Citations (Scopus)

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 1 2017
Externally publishedYes

Fingerprint

Informed Consent
Consent Forms
Alzheimer Disease
Public-Private Sector Partnerships
Information Dissemination
Privacy
Dementia
Patient Care
Therapeutics
Clinical Trials

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

Cite this

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title = "Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments",
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.",
keywords = "Alzheimer disease, Biospecimen, Consortia, Data sharing, Databases, Drug development tools, Informed consent, Regulatory sciences",
author = "{CAMD ICF working group} and Ann Hake and Dacks, {Penny A.} and Arnerić, {Stephen P.}",
year = "2017",
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language = "English (US)",
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T1 - Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments

AU - CAMD ICF working group

AU - Hake, Ann

AU - Dacks, Penny A.

AU - Arnerić, Stephen P.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - 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.

AB - 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.

KW - Alzheimer disease

KW - Biospecimen

KW - Consortia

KW - Data sharing

KW - Databases

KW - Drug development tools

KW - Informed consent

KW - Regulatory sciences

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