Data and Safety Monitoring Committees in Clinical Trials

ISBN: 9780367261276 出版年：2016 页码：266 Herson, Jay CRC Press

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