Independent Data Monitoring Committees in Clinical Trials
Taught by Dr. Jay Herson

Independent Data Monitoring Committees in Clinical Trials

taught by Jay Herson

Aim of Course:

This online course, "Independent Data Monitoring Committees in Clinical Trials" describes how the safety of clinical trials in the pharmaceutical industry is assured through Data Monitoring Committees (DMC's). It covers the statistical display and analysis methods that are appropriate for the monitoring procedures, as well as the biases and pitfalls inherent in safety review. Emerging issues in the pharmaceutical industry and their effect on the activities of a data monitoring committee are discussed. The course is illustrated throughout with real-life examples.

This course may be taken individually (one-off) or as part of a certificate program.
Course Program:

WEEK 1: Introduction and Organization of a Data Monitoring Program

  • Objectives of a Data Monitoring Committee (DMC)
    • Differences in DMC's between the NIH-sponsored trials and industry-sponsored trials
    • Issues related to the size of the sponsoring company (Big Pharma, Middle Pharma, Infant Pharma)
  • Creation of a DMC
  • Selecting members
  • Conflicts of interest
  • Role of the Data Analysis Center (DAC)

WEEK 2: Meetings and Clinical Issues

  • The DMC Charter
  • Types and structure of meetings
  • Open and closed sessions
  • Adverse event definitions and coding schemes
  • Format for meeting agendas
  • Impact of multinational trials

WEEK 3: Statistical Issues, Biases, and Pitfalls

  • Goals of statistical analysis for DMC's
  • Useful data displays
  • Frequentist, likelihood, and Bayesian analysis methods
    • Incidence
    • Rate/patient year
    • Time-to-event
  • Power
  • Multiplicity
  • Sources of bias by sponsor
  • Investigator
  • Granularity bias
  • Competing risks

WEEK 4:  DMC Decisions and Emerging Issues

  • Types of DMC decisions and the environment in which they are made
  • Risk vs. benefit analysis
  • Steps taken when a safety issue arises
  • Meta-analysis
  • Problems particular to Infant Pharma companies
  • DMC operations for safety when adaptive designs are employed for efficacy
  • Real-time SAE reporting via the internet
  • Causal inference
  • Biomarkers
  • Training of DMC members
  • Cost control, DMC audits
  • Working with internal safety review committees
  • Effect of company mergers and licensing agreements on independent safety review


Homework in this course consists of short answer questions to test concepts.

In addition to assigned readings, this course also has supplemental readings available online.

Independent Data Monitoring Committees in Clinical Trials

Who Should Take This Course:
Anyone involved with the design, implementation or analysis of clinical trials.
If you are unclear as to whether you have mastered the requirements, try these placement tests here.
Organization of the Course:
Course Text:

The course text is Data and Safety Monitoring Committees in Clinical Trials, second edition (2016) by Jay Herson, which you can order from CRC Press .




April 26, 2019 to May 24, 2019 April 24, 2020 to May 22, 2020

Independent Data Monitoring Committees in Clinical Trials


April 26, 2019 to May 24, 2019 April 24, 2020 to May 22, 2020

Course Fee: $589

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We have flexible policies to transfer to another course, or withdraw if necessary (modest fee applies)

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