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Conducting Clinical Research

Conducting Clinical Research

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作者: Judy Stone 著

出版社: Mountainside MD Press

出版时间: 2010-08

ISBN: 9780974917818

定价: 1005.20

装帧: 平装

开本: 其他

纸张: 其他

页数: 601页

正文语种: 英语

丛书: Conducting Clinical Research: A Practical Guide for Physicians

分类: 外文古旧书>英文书>文学

What's the best way to get started in clinical trials? How do I recruit volunteers? How do I traverse the ethical and political issues involved in conducting drug trials today? With the tremendous demand for clinical investigators--thousands of new investigators are needed in the United States alone--the answers to these questions is vital. Dr. Judy Stone answers these questions and more in this experienced and successful first-hand "view from the trenches." The book reveals the minefields and booby traps to avoid when entering this field， summarizes the drug development process， describes the complexities of the multiple disciplines and people that need to come together to successfully bring a drug through trial， FDA approval and to market. The book details the best practices involved in carrying out a study from landing your first study and negotiating with a drug company to recruiting and treating volunteers. Other topics include new regulations affecting research， subject injury clauses， legal and publication land mines， the unique needs of device and vaccine trials， cultural competency and health literacy， the impact of HIPAA on U.S. research， and how to survive audits. "Successfully covers . . . clinical trials. Practical considerations . . . substantial background and resource information . . . fills an important need." Annals of Internal Medicine Judy Stone, MD, is an internist and infectious disease specialist. She is Board Certified in Internal Medicine and has been conducting Phase 2 and 3 clinical trials for a variety of infectious disease indications for more than 20 years. She is a sought after speaker on the topics of anitbiotics, infectious diseases, and clinical trials.
内容简介:
What's the best way to get started in clinical trials? How do I recruit volunteers? How do I traverse the ethical and political issues involved in conducting drug trials today? With the tremendous demand for clinical investigators--thousands of new investigators are needed in the United States alone--the answers to these questions is vital. Dr. Judy Stone answers these questions and more in this experienced and successful first-hand "view from the trenches." The book reveals the minefields and booby traps to avoid when entering this field， summarizes the drug development process， describes the complexities of the multiple disciplines and people that need to come together to successfully bring a drug through trial， FDA approval and to market. The book details the best practices involved in carrying out a study from landing your first study and negotiating with a drug company to recruiting and treating volunteers. Other topics include new regulations affecting research， subject injury clauses， legal and publication land mines， the unique needs of device and vaccine trials， cultural competency and health literacy， the impact of HIPAA on U.S. research， and how to survive audits. "Successfully covers . . . clinical trials. Practical considerations . . . substantial background and resource information . . . fills an important need." Annals of Internal Medicine
作者简介:
Judy Stone, MD, is an internist and infectious disease specialist. She is Board Certified in Internal Medicine and has been conducting Phase 2 and 3 clinical trials for a variety of infectious disease indications for more than 20 years. She is a sought after speaker on the topics of anitbiotics, infectious diseases, and clinical trials.

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Conducting Clinical Research

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