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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/4033

Title: On the use of historical control data in pre-clinical safety studies
Authors: MARINGWA, John
FAES, Christel
AERTS, Marc
GEYS, Helena
Teuns, G.
Van Den Poel, B.
BIJNENS, Luc
Issue Date: 2007
Publisher: TAYLOR & FRANCIS INC
Citation: JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 17(3). p. 493-509
Abstract: A number of methods to formally incorporate historical control information in preclinical safety evaluation studies have been proposed in literature. However, it remains unclear when one should use historical data. Focusing on the logistic-normal model, we investigate situations where historical studies may prove to be useful. Aspects of estimation (precision and bias) and testing (power) for treatment effect are investigated under different conditions such as the number of historical control studies, the degree of homogeneity amongst them, the level of treatment effect and different control rates. The possibility to use a selected subset of historical control studies is also explored.
Notes: Univ Hasselt, Ctr Stat, BE-3500 Diepenbeek, Belgium. Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium.MARRINGWA, JT, Univ Hasselt, Ctr Stat, BE-3500 Diepenbeek, Belgium.john.maringwa@uhasselt.be
URI: http://hdl.handle.net/1942/4033
DOI: 10.1080/10543400701216355
ISI #: 000246725000010
ISSN: 1054-3406
Category: A1
Type: Journal Contribution
Validation: ecoom, 2008
Appears in Collections: Research publications

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