Toward strategies for the analysis of periodontal disease clinical trials.
We consider design, analysis and regulatory issues relating to clinical trials in periodontal disease and identify complications commonly associated with such studies. Alternative statistical procedures that can be used for the analyses of data from periodontal research are reviewed and a case study of the analysis of a Phase II periodontal disease clinical trial is provided to illustrate the use of one of these procedures.
Alemayehu
D
D
Medical Research Division, Lederle Laboratories, American Cyanamid Company.
Goldberg
J D
JD
Koury
K J
KJ
D000704:Analysis of Variance; D016010:Binomial Distribution; D012534:Dental Scaling; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D016014:Linear Models; D010510:Periodontal Diseases / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D012107:Research Design; D016745:Root Planing