Clinical trial quality: From supervision to collaboration and beyond

Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a...

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Bibliographic Details
Published in:Clinical trials (London, England) England), 2018-02, Vol.15 (1_suppl), p.23-26
Main Authors: Meeker-O’Connell, Ann, Glessner, Coleen
Format: Article
Language:English
Subjects:
Clinical trials
Clinical Trials as Topic - standards
Design
Humans
Leadership
Medical research
Placebo effect
Quality Improvement - organization & administration
Research Design - standards
United States
United States Food and Drug Administration
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Summary:Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.
ISSN:1740-7745
1740-7753
DOI:10.1177/1740774518755056