Orphan Therapies: Making Best Use of Postmarket Data
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11606_2014_2882_ReferencePDF.pdf
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Author(s)
Li, Lingling
Brown, Jeffrey S.
Pan, Gerald J. Dal
Maro, Judith
Date Issued
July 2014
Journal
Journal of General Internal Medicine
Publisher
Springer US
Citation
Maro, Judith C. et al. “Orphan Therapies: Making Best Use of Postmarket Data.” Journal of General Internal Medicine 29.S3 (2014): 745–751.
Version
Author's final manuscript
Abstract
Postmarket surveillance of the comparative safety and efficacy of orphan therapeutics is challenging, particularly when multiple therapeutics are licensed for the same orphan indication. To make best use of product-specific registry data collected to fulfill regulatory requirements, we propose the creation of a distributed electronic health data network among registries. Such a network could support sequential statistical analyses designed to detect early warnings of excess risks. We use a simulated example to explore the circumstances under which a distributed network may prove advantageous.
MIT Department
Massachusetts Institute of Technology. Center for Biomedical Innovation
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Article is made available in accordance with the publisher's policy and may be subject to US copyright law. Please refer to the publisher's site for terms of use.
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DOI of Published Version
https://doi.org/10.1007/s11606-014-2882-1
