• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of the advanced practitioner in oncology >Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology
【24h】

Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology

机译：肿瘤学中的临床试验设计和药物批准：肿瘤学前医生的底漆

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Evidenced-based practice requires timely and accurate integration of scientific advances. This presents a challenge for the oncology clinician given the robust pace of scientific discovery and the increasing number of new drug approvals and expanded indications for previously approved drugs. All currently available antineoplastic therapies have been developed through the clinical trials process. Advanced practitioners (APs) in oncology are often involved in the conduct of clinical trials as primary investigators, sub-investigators, study coordinators, or in the delivery and monitoring of care to patients enrolled in these trials. A prerequisite to evidenced-based practice is understanding how clinical trials are conducted and how to critically analyze published results of studies leading to U.S. Food & Drug Administration approval. Any AP involved in the clinical management and supportive care of patients receiving antineoplastic therapies should be able to critically review published data to glean findings that warrant a change in practice. The goals of this manuscript are to summarize key elements of the clinical trial process for oncology drug development and approval in the United States and to provide a primer for the interpretation of clinical data.
机译：基于证据的实践需要及时、准确地整合科学进步。鉴于科学发现的强劲步伐，新药批准的数量不断增加，以及之前批准的药物适应症不断扩大，这对肿瘤临床医生来说是一个挑战。目前所有可用的抗肿瘤疗法都是通过临床试验过程开发的。肿瘤学高级从业者（AP）通常作为主要研究者、副研究者、研究协调员参与临床试验的进行，或参与对参与这些试验的患者提供和监测护理。循证实践的先决条件是了解临床试验是如何进行的，以及如何批判性地分析导致美国食品和药物管理局批准的已发表研究结果。任何参与接受抗肿瘤治疗的患者的临床管理和支持性护理的AP都应该能够批判性地审查已发表的数据，以收集值得在实践中改变的发现。本手稿的目的是总结美国肿瘤药物开发和批准的临床试验过程的关键要素，并为临床数据的解释提供一本入门书。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号