Topic outline

  • General

    • Certificate issue 修了証発行
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  • 1. DMC Structure and Function by Dr. David DeMets and Dr. James Meaton

    In this lecture, the statisticians talk about the history and functions of DMC.

    0:00:00- [Introduction]

    0:07:30- [Part I] Data Monitoring Committee Structure & Function

    0:11:24- [I-A] Brief History of Data Monitoring Committees

    0:26:25- [I-B] DMCs for Industry-sponsored Trials

    0:35:57- [I-C] DMC Review Process

    0:43:45- [I-D] DMC Recommendations

    0:51:05- [I-E] DMC Membership

    1:00:05- [I-F] Special Issues

    1:08:42- [I-G] DMC Meeting Reports

    1:32:00- [I-H] DMC Summary


  • 2. DMC Case Studies by Dr. James Meaton and Dr. David DeMets

    In this lecture, the operational aspects of DMC are explained through case studies, and the course is then summarized.

    0:00:00- [Part II] Data Monitoring Committee Examples

    0:04:45- Trial Examples

    0:48:13- DMC Reaffirming Recommendations

    1:05:36- Trial Examples: External Data

    1:28:13- Need for Replication

    1:29:29- Sharing Data

    1:37:00- Data Lags and Subgroup Findings

    1:38:41- Importance of Statistical Analysis Center

    1:39:24- [Part III] Statistical Methods Overview

    1:39:53- [Summary and Conclusion]