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Journal article

Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice.

Abstract:

In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials registered on ClinicalTrials.gov in the 36 months before and after the guidance was issued. We noted a doubling in the number of cardiovascular outcome trials registered and a sixfold increase in the me...

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Publication status:
Published

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Publisher copy:
10.1007/s11886-011-0229-7

Authors


Bethel, MA More by this author
Journal:
Current cardiology reports
Volume:
14
Issue:
1
Pages:
59-69
Publication date:
2012-02-05
DOI:
EISSN:
1534-3170
ISSN:
1523-3782
URN:
uuid:9fefc98b-b382-4a6f-8f12-dd923b5b04c5
Source identifiers:
244761
Local pid:
pubs:244761

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