Data and safety monitoring committees in clinical trials

著者

• Herson, Jay

書誌事項

Data and safety monitoring committees in clinical trials

Jay Herson

（Chapman & Hall/CRC biostatistics series, 30）

Chapman & Hall/CRC, c2009

注記

Includes bibliographical references (p. 155-166) and index

内容説明・目次

内容説明

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

目次

Introduction What Is a Data Monitoring Committee (DMC)? Some Definitions DMC in Federal Government-Sponsored Clinical Trials versus Pharmaceutical Industry Clinical Trials Stewardship Some Recent History DMC's Place in the Drug Development Cycle6 Pharmaceutical Industry Demographics Conclusion DMCounselor Organization of a Safety Monitoring Program for a Confirmatory Trial Members of the Safety Monitoring Team How Is a DMC Created? Membership Term Conflicts of Interest Compensation Liability and Indemnification Sponsor DMC Relationship Interdisciplinary Training . Conclusion DMCounselor Meetings DMC Charter Types of Meetings Orientation Meeting Data ReviewMeetings Ad Hoc Meetings Conclusion DMCounselor Clinical Issues Goals of Safety Analysis . Definitions Safety Data Deaths . Impact of Multinational Trials Conclusion DMCounselor Statistical Issues Goals of Statistical Analysis Useful Data Displays Analysis Methods-Frequentist Power Multiplicity Analysis Methods-Likelihood Analysis Methods-Bayesian. Conclusion DMCounselor Bias and Pitfalls What Is Bias? Sources of Bias. Knowledge of Treatment Assignment Reporting Bias Competing Risks Conclusion DMCounselor Data Monitoring Committee Decisions.1 Types of DMC Decisions 1 Decision-Making Environment .2 Risk versus Benefit Analyses2 When a Safety Issue Arises.3 Information beyond the Present Trial.8 Meta-Analysis0 Final Meeting2 Special Problems with Infant Pharma Companies2 Conclusion3 DMCounselor .3 Emerging Issues9 Introduction.9 Issues in Technology.0 Issues Due to Maturing of DMC Processes and Evolution of the Pharmaceutical Industry Resignation from a DMC.0 Conclusion0 DMCounselor .1 Appendix5 Glossary1 List of Abbreviations3 References 5 Index7

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詳細情報

• NII書誌ID(NCID): BB08475068
• ISBN:
  • 9781420070378
• LCCN: 2009003127
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: Boca Raton, FL
• ページ数/冊数: xviii, 173 p.
• 大きさ: 25 cm
• 分類:
  • LCC : RM301.27
  • NLM : 2009 E-635
  • NLM : QV 771
  • DC22 : 615/.19
• 件名:
  • LCSH : Drugs -- Testing -- Evaluation
  • LCSH : Drugs -- Testing -- Statistical methods -- Evaluation
  • MESH : Clinical Trials Data Monitoring Committees -- organization & administration
  • MESH : Clinical Trials as Topic -- standards
  • MESH : Data Collection
  • MESH : Drug Industry -- standards
  • MESH : Research Design
  • MESH : Safety Management
• 親書誌ID:
  • BA8313747X