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Updated: Feb 19, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

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単一の確認型ランダム化臨床試験の中間結果と最終結果に基づく,条件付き販売認可のための統計的概念

Xiaofei Liu1,2, Nele Henrike Thomas1, Elina Asikanius3

  • 1Institute for Biostatistics, Hannover Medical School, Hannover, Germany.

Pharmaceutical statistics
|February 17, 2026
PubMed
まとめ

条件付き販売許可 (CMA) は,新薬への早期アクセスを提供します. CMA試験のための提案された二重プライマリエンドポイント戦略は,統計的に欠陥があります; グループシーケンシャルデザインのコプライマリエンドポイントは,より良い結果解釈のために推奨されます.

キーワード:
クリニック・トライアル 臨床試験条件付きの販売許可証についてコプライマリエンドポイント意思決定のプロセスダブルプライマリエンドポイントグループシーケンシャルデザイン

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