title: [Statistical considerations for preparation of a study protocol in pharmacological studies].
abstract: In order to develop a new drug with scientific rationale, it is important to design a study properly. We suggested appropriate statistical considerations in the course of planning the study that are helpful for correct evaluation of the results of a pharmacological study, the information of which will be reflected in the planning of subsequent pharmacological and clinical studies. The statistical considerations for designing a pharmacological study are as follows: 1. clarification about the purpose of the study, 2. clear statement about the endpoint of the study, 3. framing of hypotheses, 4. selection of statistical analysis method, 5. statistical considerations about study design, 6. statistical considerations of planning about statistical analysis and describing the statistical analysis. We expect researchers will be able to obtain a more reliable conclusion by preparing a study protocol taking our suggestions into consideration.
authors.affiliation: Ad Hoc Committee on Statistics, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Yamada
authors.forename: T
authors.initials: T
authors.lastname: Hashimoto
authors.forename: H
authors.initials: H
authors.lastname: Maeda
mesh_terms: D010600:Pharmacology; D012107:Research Design; D013223:Statistics as Topic