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Adaptive Designs in Clinical Drug Development —An Executive Summary of the PhRMA Working Group
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- KOMIYAMA Osamu
- Japan Pharmaceutical Manufacturers Association
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- KOSHIMIZU Takashi
- Japan Pharmaceutical Manufacturers Association
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- SUGANAMI Hideki
- Japan Pharmaceutical Manufacturers Association
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- SAKAI Hironori
- Japan Pharmaceutical Manufacturers Association
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- ORIHASHI Yasushi
- Japan Pharmaceutical Manufacturers Association
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- TOHMIYA Hideo
- Japan Pharmaceutical Manufacturers Association
Bibliographic Information
- Other Title
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- 医薬品の臨床開発におけるアダプティブ・デザイン‐米国研究製薬工業協会ワーキング・グループのエグゼクティブ・サマリー邦訳‐
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Description
A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is currently in preparation. This article is an Executive Summary of that full White Paper; it summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where adaptive designs can likely be utilized beneficially are discussed: dose finding, seamless Phase II/III trial designs, and sample size reestimation.
Journal
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- Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
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Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 40 (6), 303-310, 2009
The Japanese Society of Clinical Pharmacology and Therapeutics
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Keywords
Details 詳細情報について
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- CRID
- 1390282680345417216
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- NII Article ID
- 130004541349
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- ISSN
- 18828272
- 03881601
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed