Design and statistical aspects of the management of clinical trials to assess antihypersensitivity product efficacy.
This paper discusses the design of clinical trials for testing the efficacy of therapeutic products for hypersensitive teeth with emphasis on statistical considerations. The preparation of a proper protocol is essential to the successful outcome of any clinical study. Key considerations in this regard are the criteria for patient selection, the size of the sample, the method of stratification of subjects into various test and control groups, the methods to be used for assessing sensitivity, and the statistical treatment of the data generated. The importance of other factors such as the requirement for a quiet, relaxed atmosphere and allowing adequate time for the examiner to establish a rapport with the subject, and the need to comply with institutional review board regulations, are stressed.
Kaufman
H W
HW
Department of Oral Biology and Pathology, School of Dental Medicine, SUNY at Stony Brook 11794-8702.
Kleinberg
I
I
D000704:Analysis of Variance; D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D003807:Dentin Sensitivity / Q000188:drug therapy*; D006801:Humans; D016015:Logistic Models; D018579:Patient Selection; D012107:Research Design; D018401:Sample Size; D018709:Statistics, Nonparametric; D014481:United States; D014486:United States Food and Drug Administration