Data Safety Monitoring Boards: A Bioethical Perspective
暫譯: 數據安全監測委員會：生物倫理的視角

Barnbaum, Deborah R., Wittes, Janet

Data Safety Monitoring Boards: A Bioethical Perspective
  • 出版商: MIT
  • 出版日期: 2025-08-12
  • 售價: $1,810
  • 貴賓價: 9.5 折 $1,720
  • 語言: 英文
  • 頁數: 202
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0262552744
  • ISBN-13: 9780262552745

    • 尚未上市，無法訂購

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商品描述

A critical and underexplored area of bioethics--ethical issues that emerge from the data monitoring of clinical trials.

Data Safety Monitoring Boards explores ethical issues confronted by data safety monitoring boards, or DSMBs, overseeing large randomized clinical trials. DSMBs meet on a regular basis to ensure that the expected benefits of a study continue to outweigh its risks and that side effects are monitored. They are empowered to recommend to study sponsors that studies be halted if ethical protections fail.

Written by bioethicist Deborah Barnbaum, who has served as a clinical ethicist and patient advocate on several DSMBs for the National Institutes of Health since 2006, this book combines compelling narratives about clinical trials, the ethical quandaries that emerge when overseeing those studies, and the theoretical considerations that guide the practices of DSMBs.

商品描述(中文翻譯)

生物倫理學中一個關鍵且未被充分探討的領域——臨床試驗數據監控所產生的倫理問題。

數據安全監控委員會 探討了數據安全監控委員會（Data Safety Monitoring Boards，簡稱 DSMBs）在監督大型隨機臨床試驗時所面臨的倫理問題。DSMBs 定期會議，以確保研究的預期利益持續超過其風險，並監控副作用。如果倫理保護失效，他們有權建議研究贊助者停止研究。

本書由生物倫理學家 Deborah Barnbaum 撰寫，自 2006 年以來，她在美國國立衛生研究院的多個 DSMBs 擔任臨床倫理學家和病人倡導者。本書結合了關於臨床試驗的引人入勝的敘述、在監督這些研究時出現的倫理困境，以及指導 DSMBs 實踐的理論考量。

作者簡介

Deborah R. Barnbaum is Professor of Philosophy at Kent State University. In 2009, she received the bronze medal in the Health/Medicine/Nutrition category of the Independent Book Publishers Awards for her book The Ethics of Autism.

作者簡介(中文翻譯)

黛博拉·R·巴恩鮑姆（Deborah R. Barnbaum）是肯特州立大學（Kent State University）的哲學教授。2009年，她因其著作《自閉症的倫理》（The Ethics of Autism）在獨立書籍出版商獎（Independent Book Publishers Awards）中獲得健康/醫學/營養類別的銅獎。

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