Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan.

Sakamaki, Kentaro; Yoshida, Seitaro; Morita, Yusuke; Kamiura, Toshifumi; Iba, Katsuhiro; Ogawa, Naoyuki; Suganami, Hideki; Tsuchiya, Satoru; Fukimbara, Satoru

Sakamaki, Kentaro; Yoshida, Seitaro; Morita, Yusuke; Kamiura, Toshifumi; Iba, Katsuhiro; Ogawa, Naoyuki; Suganami, Hideki; Tsuchiya, Satoru; Fukimbara, Satoru.

Afiliación

Sakamaki K; 1 Department of Biostatistics and Bioinformatics, The University of Tokyo, Tokyo, Japan.
Yoshida S; 2 Center for Data Science, Yokohama City University, Yokohama, Japan.
Morita Y; 3 Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
Kamiura T; 4 Clinical Information & Intelligence Department, Chugai Pharmaceutical Co, Ltd, Tokyo, Japan.
Iba K; 3 Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
Ogawa N; 5 Clinical Data Science and Affairs, Kyorin Pharmaceutical Co, Ltd, Tokyo, Japan.
Suganami H; 3 Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
Tsuchiya S; 6 Data Science Department, Nippon Shinyaku Co, Ltd, Kyoto, Japan.
Fukimbara S; 3 Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.

Ther Innov Regul Sci ; : 2168479019855994, 2019 Jun 18.

Article en En | MEDLINE | ID: mdl-31213076

Palabras clave

determination of endpoint; industry survey; multiple endpoints; multiplicity adjustment; terminology

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Tipo de estudio: Guideline / Qualitative_research Idioma: En Revista: Ther Innov Regul Sci Año: 2019 Tipo del documento: Article País de afiliación: Japón

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