Safety Monitoring Committees in Clinical Trials

This course covers the statistical display and analysis methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review.

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

Safety Monitoring Committees in Clinical Trials

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Safety Monitoring Committees in Clinical Trials

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.

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

This course takes place over the internet, at statistics.com 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.

The course 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, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and you will receive individual feedback on your homework answers.

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 (Program in Advanced 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).

As you begin the class, you will be asked to specify your category.

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 record of course completion will be issued by Statistics.com, upon request.

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.

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