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A method of designing clinical trials for combination drugs
Author(s) -
Pigeon Joseph G.,
Copenhaver Margaret Diponzio,
Whipple James P.
Publication year - 1992
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780110808
Subject(s) - clinical trial , computer science , sample size determination , drug , factorial experiment , medicine , medical physics , machine learning , pharmacology , statistics , mathematics
Many pharmaceutical companies are now exploring combination drug therapies as an alternative to monotherapy. Consequently, it is of interest to investigate the simultaneous dose response relationship of two active drugs to select the lowest effective combination. In this paper, we propose a method for designing clinical trials for drug combinations that seems to offer several advantages over the 4 × 3 or even larger factorial studies that have been used to date. In addition, our proposed method provides a convenient formula for calculating the required sample size.