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A consultant's perspective on the regulatory hurdles to adaptive trials. | LitMetric

A consultant's perspective on the regulatory hurdles to adaptive trials.

Biom J

Cytel Inc., 675 Massachusetts Ave., Cambridge, MA 02139-3309, USA.

Published: August 2006

This is a discussion of the following two papers appearing in this special issue on adaptive designs: 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.

Download full-text PDF

Source
http://dx.doi.org/10.1002/bimj.200610249DOI Listing

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