Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan

被引：0

作者：

Kentaro Sakamaki

Yusuke Morita

Katsuhiro Iba

Toshifumi Kamiura

Seitaro Yoshida

Naoyuki Ogawa

Hideki Suganami

Satoru Tsuchiya

Satoru Fukimbara

机构：

[1] The University of Tokyo,Department of Biostatistics and Bioinformatics

[2] Yokohama City University,Center for Data Science

[3] Japan Pharmaceutical Manufacturers Association,Data Science Expert Committee, Drug Evaluation Committee

[4] Kyorin Pharmaceutical Co.,Clinical Data Science and Affairs

[5] Ltd.,Department of Biometrics

[6] Otsuka Pharmaceutical Co.,Data Science Department

[7] Ltd.,Clinical Information & Intelligence Department

[8] Nippon Shinyaku Co.,Clinical Development Department

[9] Ltd.,Clinical Data Science Department

[10] Chugai Pharmaceutical Co.,Data Science

[11] Ltd.,Data Science

[12] Sanwa Kagaku Kenkyusho Co.,undefined

[13] Ltd.,undefined

[14] Kowa Company,undefined

[15] Ltd.,undefined

[16] Sumitomo Dainippon Pharma Co.,undefined

[17] Ltd.,undefined

[18] Ono Pharmaceutical Co.,undefined

[19] Ltd.,undefined

来源：

Therapeutic Innovation & Regulatory Science | 2020年 / 54卷

关键词：

Multiple endpoints; Multiplicity adjustment; Sample size calculation; Survey of current practices;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

引用

页码：1097 / 1105

页数：8

共 50 条

[1] Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan
Sakamaki, Kentaro
Morita, Yusuke
Iba, Katsuhiro
Kamiura, Toshifumi
Yoshida, Seitaro
Ogawa, Naoyuki
Suganami, Hideki
Tsuchiya, Satoru
Fukimbara, Satoru
[J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (05) : 1097 - 1105
[2] Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan
Kentaro Sakamaki
Toshifumi Kamiura
Yusuke Morita
Katsuhiro Iba
Seitaro Yoshida
Akira Wakana
Satoru Tsuchiya
Satoru Fukimbara
Hideki Suganami
[J]. Therapeutic Innovation & Regulatory Science, 2016, 50 : 846 - 852
[3] Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan
Sakamaki, Kentaro
Kamiura, Toshifumi
Morita, Yusuke
Iba, Katsuhiro
Yoshida, Seitaro
Wakana, Akira
Tsuchiya, Satoru
Fukimbara, Satoru
Suganami, Hideki
[J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2016, 50 (06) : 846 - 852
[4] Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan
Kentaro Sakamaki
Seitaro Yoshida
Yusuke Morita
Toshifumi Kamiura
Katsuhiro Iba
Naoyuki Ogawa
Hideki Suganami
Satoru Tsuchiya
Satoru Fukimbara
[J]. Therapeutic Innovation & Regulatory Science, 2020, 54 : 528 - 533
[5] 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
[J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (03) : 528 - 533
[6] Multiplicity adjustment for multiple endpoints in clinical trials with multiple doses of an active treatment
Quan, H
Luo, XH
Capizzi, T
[J]. STATISTICS IN MEDICINE, 2005, 24 (14) : 2151 - 2170
[7] Sample size calculation for complex clinical trials with survival endpoints
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[J]. CONTROLLED CLINICAL TRIALS, 1995, 16 (06): : 395 - 407
[8] Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints
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[J]. STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2024, 16 (01): : 104 - 115
[9] Sample size optimization for clinical trials using graphical approaches for multiplicity adjustment
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[J]. STATISTICS IN MEDICINE, 2023, 42 (28) : 5229 - 5246
[10] Sample size calculations with multiplicity adjustment for longitudinal clinical trials with missing data
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[J]. STATISTICS IN MEDICINE, 2012, 31 (01) : 19 - 28

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