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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/15198

Title: Omics-based clinical trial designs
Authors: BUYSE, Marc
Michiels, Stefan
Issue Date: 2013
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Citation: CURRENT OPINION IN ONCOLOGY, 25 (3), p. 289-295
Abstract: Purpose of review The derivation of signatures using -omics technologies is increasingly integrated in the design of clinical trials in oncology. In this review, we investigate the clinical trial designs for the validation of prognostic and predictive signatures. Recent findings Using real-life breast cancer trial examples, we highlight the pros and cons of clinical utility designs for prognostic signatures. For predictive signatures, we first review alternative procedures to test the effect of treatment in the overall population as well as in the signature-positive or signature-negative subgroup. We proceed to show why the recent literature on signature-based strategy designs discourages the use of this design. We conclude by discussing adaptive signature designs to identify and validate a signature in a single trial using cross-validation techniques. Summary Use of -omics technologies should not be an add-on to clinical trials, it must become an integral part of their design.
Notes: Buyse, M (reprint author) Int Inst Drug Dev, B-1340 Louvain, Belgium. Hasselt Univ, Interuniv Inst Biostat, Hasselt, Belgium. Inst Gustave Roussy, Dept Biostat & Epidemiol, Paris, France. marc.buyse@iddi.com
URI: http://hdl.handle.net/1942/15198
DOI: 10.1097/CCO.0b013e32835ff2fe
ISI #: 000317114300012
ISSN: 1040-8746
Category: A1
Type: Journal Contribution
Validation: ecoom, 2014
Appears in Collections: Research publications

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