JSM 2004 - Toronto

Abstract #300993

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Activity Number: 156
Type: Contributed
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300993
Title: Estimating Relative Potency in Direct Assays Containing Nonresponders
Author(s): Daniel C. Bonzo*+ and Eugene Laska
Companies: Serono, Inc. and Nathan S. Kline Institute for Psychiatric Research
Address: One Technology Place, Rockland, MA, 02370,
Keywords: relative potency ; tolerance dose ; nonresponders ; cure models ; delta method ; Fieller's method
Abstract:

Relative potency plays a key role in understanding the relationship between the doses of two treatments. Defined as the ratio of equally effective doses, it is central to communicating the relationship between a new drug entering the market and older medications. Because doses are not continuous, estimation in direct assays is hampered by the fact that tolerances are usually only available as grouped data which is frequently left- or right-censored information or both. This problem was considered in Bonzo, Friedman, and Laska (2003), which modeled premature discontinuation of treatment. However, further difficulties arise when there are nonresponders, regardless of dose, in the population. We propose an extension of our previous work for estimating relative potency in this setting that utilizes a cure model to characterize the tolerance dose distribution. The delta method and a large sample version of Fieller's theorem are used to construct confidence interval estimates. An example utilizing data that is typical of analgesic trials is given to illustrate the method's use.

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