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Safety Monitoring Committees in Clinical Trials

Dr. Jay Herson

Aim of Course:

This course 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.

Who Should Take This Course:

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

For those enrolled in a Program of Advanced Statistical Studies, this is a required or elective course in the following Programs:

  • Biostatistics (controlled trials) - required

Course Program:

The course is structured as follows:

SESSION 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)
SESSION 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
SESSION 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
SESSION 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

The Instructor:

Dr. Jay Herson is currently serving on the adjunct faculty in Biostatistics at the Johns Hopkins Bloomberg School of Public Health. His previous positions included Senior Biostatistician at the University of Texas MD Anderson Cancer Center and as president of the contract research organization he founded known as Applied Logic Associates. Under his leadership ALA grew from a solo consultancy to a 50-person full-service CRO with global capabilities. Dr. Herson started the first Data Monitoring Committee (DMC) in the pharmaceutical industry and has Chaired or served on 25 DMCs. He is author of numerous papers on statistical methodology and authored the book Data and Safety Monitoring Committees in Clinical Trials, published by Chapman and Hall/CRC Press, March, 2009.

Organization of the Course:

The course takes place over the internet, at statistics.com. 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. The course is scheduled to take place over 4 weeks, and typically requires 15 hours per week. 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 and work through exercises. Discussion among participants is encouraged. The instructor will provide answers and comments.

Certificates and Grades:

You may be interested only in learning the material presented, and not be concerned with grades or certificates. Or you may be enrolled in a statistics.com Program in Advanced Statistical Studies that requires demonstration of proficiency in the subject, in which case your work will be assessed for purposes of issuing a grade. Or you may require only a "Certificate of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). As you begin the class, you will be asked to specify your category.

Credit:

This course offers continuing education units (CEU's). For those successfully completing the course (generally this means marks of 50% or better on the homework), 5.0 CEU's and a certificate will be issued by statistics.com, upon request.

Dates:

Sep. 24 - Oct. 22, 2010
Click here to be notified of future course offerings.

Participants gain access to the online materials on the first day of the course, and typically spend about 15 hours per week (at their convenience). You retain full access to course materials, including discussion board, for two weeks after the course closing date.

Level:

intermediate/introductory

Prerequisite:

The equivalent of Introduction to Statistics 1: Inference for a Single Variable, Introduction to Statistics 2: Working with Bivariate Data, and Introduction to Clinical Trial Statistics. (If necessary before these courses, Introduction to Statistics for Beginners or Survey of Statistics for Beginners).

Course Text:

The text is Data and Safety Monitoring Committees in Clinical Trials by Jay Herson, published by CRC Press. You can order it online here. CRC Press offers a discount on the text but you must use this form to get the discount.

Registration:

Register Online - $499
Register Online (academic) - $399 (you must be affiliated with a college, university or high school)

Add $50 service fee if you require a prior invoice, or if you need to submit a purchase order or voucher, pay by wire transfer or EFT, or refund and reprocess a prior payment. Please use this printed registration form, for these and other special orders.

Consider registering for this course together with two other Clinical Trials courses as part of our special 3 course package registration for tuition savings.

Note: Courses may fill up at any time and registrations are processed in the order in which they are received. Your registration will be confirmed for the first available course date, unless you specify otherwise.

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