Abstract Details
Activity Number:
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385
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312232
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View Presentation
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Title:
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When Is Data Transparency Useful?
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Author(s):
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Michael Hale*+
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Companies:
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Amgen
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Keywords:
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Transparency ;
Data Sharing ;
Privacy ;
Personal Health Information
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Abstract:
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Is sharing of clinical trials data equivalent to transparency? Most discussions of sharing data appear to presume so, using the terms interchangeably. We propose they may not be equivalent; if not, can the high level goals of transparency be met by sharing data? What conditions protect privacy and confidential commercial information without limiting usefulness of shared data? Opinions diverge on basic principles and degree of sharing, ranging from sharing for qualified research (e.g., "PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing") to "publicly accessible", as in Gøtzsche's (BMJ, 2012) call for European law to specify that "trial data belong to society", rejecting drug applications otherwise. Efforts are progressing among regulators, legislators, and individual pharma/biotech companies, with several companies developing policies and procedures for the qualified sharing of data with researchers requesting data for specific research purposes. This talk considers the goals of transparency, how data sharing addresses those, and implications under conditions ranging from society ownership to qualified research access.
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Authors who are presenting talks have a * after their name.
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