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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/22802

Title: Implementation Issues in Adaptive Design Trials
Authors: Danielson, Linda
Carlier, Jerome
Burzykowski, Tomasz
Buyse, Marc
Issue Date: 2014
Publisher: Springer
Citation: He, Weili; Pinheiro, Jose; Kuznetsova, Olga M. (Ed.). Practical Considerations for Adaptive Trial Design and Implementation, Springer, p. 225-240
Series/Report: Statistics for Biology and Health
Abstract: In this chapter we discuss operational challenges that are specific to adaptive trials (as well as complex nonadaptive trials): essentially, the need to validate the design, to control the trial centrally, to collect and analyze key data rapidly, to preserve the trial blinding and integrity, and to document all important adaptive decisions taken. We illustrate these challenges using an actual phase I trial in oncology, and argue that the issues can be addressed through proper planning, choice of experienced vendors and independent groups (coordinating center and DSMB), statistical teams with adequate expertise in the design chosen (randomization and CRM), recourse to efficient computer technology (IWRS, EDC, automated e-mailing), and oversight by a team that must be as flexible as the trial design!
URI: http://hdl.handle.net/1942/22802
DOI: 10.1007/978-1-4939-1100-4_12
ISBN: 9781493910991
ISSN: 1431-8776
Category: B2
Type: Book Section
Appears in Collections: Research publications

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