Testing principles in clinical and preclinical trials =
Subtitle: Testprinzipien in klinischen und praklinischen studien
By: edited by Joachim Vollmar.
Contributors: Vollman, Joachim.
Series: Biometrie in der chemisch-pharmazeutischen industrie -- 6.
Publisher: Gustav Fischer Verlag
Published: 1995
Place of publication: Stuttgart; New York
Language: eng
Number of pages: 133
Subjects: Drugs -- Testing -- Mathematical models.; Clinical pharmacology -- Mathematical models.; Biometry -- Research.; Clinical trials -- Research.; Pharmaceutical chemistry -- Statistical methods.
Description: Multiple hypothesis testing arises when several questions are to be answered on the basis of the results of a single experiment. With this 6th volume of the series "Biometrics in the Chemical/Pharmaceutical Industry" we have an assortment of articles, covering a great variety of problems and possible solutions. Multiple testing is of central importance with regard to effect assessment, not only in preclinical, but also in clinical studies. Associated with this is the inherent loss of power caused by keeping the experimentwise level of Type I error at a specified level. By using the closed test principle, new test procedures can be developed that maintain the Type I error without a large reduction in power. These procedures apply to studies with multiple endpoints and studies with repeated measurements, as well as to studies with a known order of comparison with respect to importance. Examples of these last kinds of studies are order relation in dose-finding studies, comparison of a combination therapy with each mono therapy and the placebo group, comparison of a new therapy with the standard therapy and with the placebo, comparison of dose groups with the negative control group taking into consideration the positive control group, and cross-over studies considering possible residual effects.
Notes: Includes bibliographical references.