Tuesday, 9 October 2012

Safety Monitoring Committees in Clinical Trials

In 1989, a drug was found to be effective in controlling heart arrhythmias, but it paradoxically increased the rate of arrhythmic death.  Who watches over clinical trials as they happen, looking out for unusual outcomes, protecting the patients, and assuring integrity of the study?  This is the job of the Data and Safety Monitoring Committee, a specialty of Dr. Jay Herson (a pioneer in this area), who will teach his online course "Safety Monitoring Committees in Clinical Trials" at Statistics.com. For more details please visit at http://www.statistics.com/ClinicalMonitoring/.

"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.

Who Should Take This Course:
Anyone involved with the design, implementation or analysis of clinical trials.

Course Program:

Course outline: 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

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.

You will be able to ask questions and exchange comments with Dr. Sudha Purohit via a private discussion board throughout the course.   The courses take place online at statistics.com in a series of 4 weekly lessons and assignments, and require about 15 hours/week.  Participate at your own convenience; there are no set times when you must be online. You have the flexibility to work a bit every day, if that is your preference, or concentrate your work in just a couple of days.

For Indian participants statistics.com accepts registration for its courses at special prices in Indian Rupees through its partner, the Center for eLearning and Training (C-eLT), Pune.

For India Registration and pricing, please visit us at www.india.statistics.com.

Call: 020 66009116


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