Clinical Trials - Monitoring

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Safety Monitoring Committees in Clinical Trials

taught by Jay Herson

Aim of Course:

This online course, "Safety Monitoring Committees in Clinical Trials" describes how the safety of clinical trials in the pharmaceutical industry is assured through Data and Safety 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 safety 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 Safety 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:

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.


Safety Monitoring Committees in Clinical Trials

Who Should Take This Course:

Anyone involved with the design, implementation or analysis of clinical trials.

Level:

intermediate/introductory

Prerequisite:
If you are unclear as to whether you have mastered the requirements, try these placement tests here.


Organization of the Course:

This course takes place online at the Institute for 4 weeks. During each course week, you participate at times of your own choosing - there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor.

At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and at the end of the week, you will receive individual feedback on your homework answers.

Time Requirement:
About 15 hours per week, at times of  your choosing.

Credit:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:

  1. You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
  2. You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
  3. You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's).  For those successfully completing the course,  CEU's and a record of course completion will be issued by The Institute, upon request.


Course Text:

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

PLEASE ORDER YOUR COPY IN TIME FOR THE COURSE STARTING DATE.

Software:

None


Safety Monitoring Committees in Clinical Trials

Instructor(s):
Dates:
April 28, 2017 to May 26, 2017April 27, 2018 to May 25, 2018April 26, 2019 to May 24, 2019

Course Fee: $589