title: [Statistical considerations for preparation of a study report on pharmacological studies].
abstract: In order to develop a new drug with scientific rationale, it is important to collect and analyze data in accordance with the protocol and to report it correctly. We suggested appropriate statistical considerations with regards to the following five points for preparing a study report on a pharmacological study: 1. For describing statistical analysis, it is important to describe the applied statistical methods concretely; 2. For describing subjects included in the analysis, it is necessary to describe the number of subjects excluded from analysis along with the reasons for their exclusion, and it is important to describe the comparability among groups; 3. For preparation of tables and figures, it is necessary to prepare tables and figures with sufficient statistical information; 4. For proper expression of the results and a meaningful discussion, we suggested the importance of drawing pharmacological conclusions with sufficient knowledge of the applied statistical methods and also suggested the statistical considerations for utilizing information obtained from the results; 5. For compiling an integrated report from two or more study reports, we suggested statistical considerations for discussing the consolidated results. We expect researchers will be able to obtain more reliable conclusions by preparing a study report taking our suggestions into consideration.
authors.affiliation: Ad Hoc Committee on Statistics, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hashimoto
authors.forename: M
authors.initials: M
authors.lastname: Yamada
authors.forename: H
authors.initials: H
authors.lastname: Maeda
mesh_terms: D000818:Animals; D015233:Models, Statistical; D010600:Pharmacology / Q000379:methods; D013223:Statistics as Topic