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Trials
Published in: Trials 2/2015

Open Access 01-12-2015 | Poster presentation

Impact of retrospective data verification on the results of the academic-led ICON6 trial

Authors: Andrew Embleton, Elizabeth Clark, Stephen Townsend, Laura Farrelly, Cheryl Jones, Richard Kaplan

Published in: Trials | Special Issue 2/2015

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Excerpt

ICON6 (ISRCTN68510403) is a phase III academic-led international double-blind placebo-controlled randomised trial of the addition of cediranib to chemotherapy in recurrent ovarian cancer. The trial established a beneficial gain in progression-free survival (PFS), conducted using the long established risk-based monitoring model as advocated by FDA/EMA as an alternative to the traditional monitoring-intensive industry approach. AstraZeneca are currently considering regulatory submissions using ICON6 as the single pivotal trial. …
Metadata
Title
Impact of retrospective data verification on the results of the academic-led ICON6 trial
Authors
Andrew Embleton
Elizabeth Clark
Stephen Townsend
Laura Farrelly
Cheryl Jones
Richard Kaplan
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue Special Issue 2/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-16-S2-P184

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