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Navigating the Valley of Death: How Evidence is Evaluated in Phase 2 Trial Initiation

Navigating the Valley of Death: How Evidence is Evaluated in Phase 2 Trial Initiation
穿越死亡之谷:第二阶段试验启动时如何评估证据
批准号:
434533
负责人:
Kimmelman Jonathan
金额:
$28.42万
依托单位:
依托单位国家:
加拿大
项目类别:
Operating Grants
财政年份:
2020
资助国家:
加拿大
项目状态:
已结题
起止时间:
2020-10-01 至 2024-10-01

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中文摘要
翻译
绝大多数在患者身上进行试验的新药都不能证明足够的安全性和有效性,无法获得批准。大多数失败发生在“第二阶段”临床试验中,这一阶段旨在首次显示药物对患者的疗效
英文摘要
The vast majority of new drugs tested in patients fail to demonstrate enough safety and efficacy to receive approval. Most of this failure occurs in "phase 2" clinical trials- a stage of testing aimed at showing drug efficacy in patients for the first tim
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Regulatory, Policy and Ethical Implications of Clinical Trial Portfolios
  • 批准号:
    402661
  • 项目类别:
    Operating Grants
  • 资助金额:
    $38.73万
  • 财政年份:
    2019
  • 负责人:
    Kimmelman Jonathan
  • 依托单位:
Ethics, Efficiency and Patient Burden in Drug Development
  • 批准号:
    345282
  • 项目类别:
    Operating Grants
  • 资助金额:
    $26.73万
  • 财政年份:
    2016
  • 负责人:
    Kimmelman Jonathan
  • 依托单位:
Can Researchers Predict Trial Outcomes and Feasibility? An Empirical Investigation
  • 批准号:
    286082
  • 项目类别:
    Operating Grants
  • 资助金额:
    $20.4万
  • 财政年份:
    2013
  • 负责人:
    Kimmelman Jonathan
  • 依托单位:
Signal, Safety, and Success: An Analysis of Risk, Benefit, and Translation after Detection of Clinical Activity in Drug Development
  • 批准号:
    238820
  • 项目类别:
    Operating Grants
  • 资助金额:
    $23.3万
  • 财政年份:
    2011
  • 负责人:
    Kimmelman Jonathan
  • 依托单位:
海外基金