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New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

机译:新的基于证据的适应性临床试验方法,可将预测生物标志物最佳地整合到肿瘤学临床开发计划中

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摘要

Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy,increase the value of cancer medicines,and decrease the size and cost of clinical trials while increasing their chance of success.But predictive biomarkers do not always work.When unsuccessful,they add cost,complexity,and time to drug development.This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes.In the end,the biomarker is emphasized to the extent that it can actually predict.
机译:预测性生物标志物对于肿瘤学的未来至关重要。它们可用于识别将从治疗中受益,增加抗癌药物价值,减小临床试验规模和成本,同时增加其成功机会的患者人群,但预测性生物标志物并不总是有效。当失败时,它们会增加成本,复杂性和药物开发时间。此透视图描述了阶段2和3的开发方法,这些方法可以有效地自适应检查生物标记物预测临床结果的能力。最后,重点强调了生物标记物可以实际预测的程度。

著录项

  • 来源
    《癌症(英文版)》 |2013年第005期|233-241|共9页
  • 作者

    Robert A.Beckman; Cong Chen;

  • 作者单位

    Oncology Clinical Research, Daiichi Sankyo Pharmaceutical Development, Edison, New Jersey 08837, USA;

    Center for Evolution and Cancer, Helen Diller Family Cancer Center, University of California at San Francisco, San Francisco, California 94115, USA;

    Biostatistics and Research Decision Sciences, Merck & Co., North Wales, Pennsylvania 19454, USA;

  • 收录信息 中国科学引文数据库(CSCD);中国科技论文与引文数据库(CSTPCD);
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

  • 入库时间 2022-08-19 03:43:41
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