05-04-2000
The three-period crossover design in Phase I clinical research analysis and efficiency issuesPieta BoonTo assess the efficacy of potential new drugs in the initial phase of clinical research, an efficient design has to be used which satisfies some conditions to guarantee the safety of the subjects. Compared to some other designs, an appropriate three-period crossover design turns out to be the most efficient. Several difficulties occurring in the analysis of data from the crossover design are dealt with, e.g. the inhomogeneity of variances for the (correlated) observations and the presence of repeated measurements. The latter occur firstly because each subject receives doses in three periods, which can introduce carry-over effects, secondly because in each dose period several measurements are taken for which a representative summary measure has to be found. |
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05-04-2000 |
