Articles with "pivotal trials" as a keyword



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Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs

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Published in 2022 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2022.0035

Abstract: This cross-sectional study evaluates the representation of women as authors of pivotal trials of novel cardiovascular drugs approved by the US Food and Drug Administration between 2008 and 2020. read more here.

Keywords: representation women; novel cardiovascular; pivotal trials; authors pivotal ... See more keywords
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Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis

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Published in 2023 at "BMJ Open"

DOI: 10.1136/bmjopen-2022-068981

Abstract: Objectives To describe the characteristics of clinical study report (CSR) documents published by the European Medicines Agency (EMA), and for included pivotal trials, to quantify the timeliness of access to trial results from CSRs compared… read more here.

Keywords: medicines agency; published european; european medicines; clinical study ... See more keywords