Independent Data Monitoring Committees in Clinical Trials

Independent Data Monitoring Committees in Clinical Trials

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

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

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Overview

This course describes how Data Monitoring Committees (DMC’s) ensure the safety of clinical trials in the pharmaceutical industry. It explains appropriate statistical display and analysis methods for 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.

Learning Outcomes

At the conclusion of this course students will have a basic understanding of the objectives of a Data Monitoring Committee (DMC) and the role of a Data Analysis Center. They will learn how to create and administer a DMC, how to approach meaningful statistical analyses, and how to make data-driven DMC decisions.

  • Explain how to set up a data monitoring committee
  • Explain how the commmittee conducts business
  • Define adverse events
  • Describe the statistical analysis goals for DMC’s
  • Specify the issues of bias and multiplicity to be alert for
  • Describe emerging issues such as biomarkers and causal analysis

Who Should Take This Course

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

Instructors

dr-jay-herson

Dr. Jay Herson

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.
See Instructor Bio

Course Syllabus

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

  • 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

Class Dates

2019

No classes scheduled at this time.

2020

Apr 24, 2020 to May 22, 2020

2021

Apr 24, 2021 to May 21, 2021

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Prerequisites

Introductory Statistics

We assume you are versed in statistics or have the equivalent understanding of topics covered in our Statistics 1 and Statistics 2 courses. but do not require them as eligibility to enroll in this course. Please review the course description for each of our introductory statistics courses, estimate which best matches your level of understanding of the material covered in these courses, then take the short assessment test for that course. If you can not answer more than half of the questions correctly, we suggest you take our Statistics 1 and Statistics 2 courses prior to taking this course.

The courses listed below are prerequisites for enrollment in this course:

Introduction to Statistical Issues in Clinical Trials

This course will teach you the basic statistical principles in the design and analysis of randomized controlled trials.
Topic: Statistics, Biostatistics | Skill: Introductory | Credit Options: CEU
Class Start Dates: Dec 7, 2019, Jun 12, 2020, Dec 4, 2020

Statistics 1 – Probability and Study Design

This course, the first of a three-course sequence, provides an introduction to statistics for those with little or no prior exposure to basic probability and statistics.
Topic: Statistics, Introductory Statistics | Skill: Introductory | Credit Options: ACE, CAP, CEU

Statistics 2 – Inference and Association

This course, the second of a three-course sequence, will teach you the use of inference and association through a series of practical applications, based on the resampling/simulation approach, and how to test hypotheses, compute confidence intervals regarding proportions or means, computer correlations, and use of simple linear regressions.
Topic: Statistics, Introductory Statistics | Skill: Introductory | Credit Options: ACE, CEU
Class Start Dates: Dec 6, 2019

What Our Students Say​

The material covered here will be indispensable in my work. I can't wait to take other courses. Great work!

Stephen McAllister
Ottawa Public Library

I learned more in the past 6 weeks than I did taking a full semester of statistics in college, and 10 weeks of statistics in graduate school. Seriously.

Amir Aminimanizani
MRR Pharmacy Consulting, Inc

Frequently Asked Questions

What is your satisfaction guarantee and how does it work?

We offer a “Student Satisfaction Guarantee​” that includes a tuition-back guarantee, so go ahead and take our courses risk free. That’s our commitment to student satisfaction. Students may cancel, transfer, or withdraw from a course under certain conditions. If you’re not satisfied with a course, you may withdraw from the course and receive a tuition refund.

Please see our knowledge center for more information.

Who are the instructors at the Institute?

The Institute has more than 60 instructors who are recruited based on their expertise in various areas in statistics. Our faculty members are:

  • Authors of well-regarded texts in their area;
  • Advisory board members;
  • Senior faculty; and
  • Educators who have made important contributions to the field of statistics or online education in statistics.

The majority of our instructors have more than five years of teaching experience online at the Institute.

Please visit our faculty page for more information on each instructor at The Institute for Statistics Education.

Please see our knowledge center for more information.

What type of courses does the Institute offer?

The Institute offers approximately 80 courses each year. Topics include basic survey courses for novices, a full sequence of introductory statistics courses, bridge courses to more advanced topics. Our courses cover a range of topics including biostatistics, research statistics, data mining, business analytics, survey statistics, and environmental statistics.

Please see our course search or knowledge center for more information.

Do your courses have for-credit options?

Our courses have several for-credit options:

  • Continuing education units (CEU)
  • College credit through The American Council on Education (ACE CREDIT)
  • Course credits that are transferable to the INFORMS Certified Analytics Professional (CAP®)

Please see our knowledge center for more information.

Is the Institute for Statistics Education certified?

The Institute for Statistics Education is certified to operate by the State Council of Higher Education for Virginia (SCHEV). For more information visit: http://www.schev.edu

Please see our knowledge center for more information.

Visit our knowledge base and learn more.

FAQs + Knowledge Base

Related Courses

Clinical Trials – Phamacokinetics and Bioequivalence

This course will teach you the statistical measurement and analysis methods relevant to the study of pharmacokinetics, dose-response modeling, and bioequivalence. The course provides practical work with actual/simulated clinical trial data.
Topic: Statistics, Biostatistics | Skill: Intermediate | Credit Options: CEU
Class Start Dates: Jul 17, 2020

Independent Data Monitoring Committees in Clinical Trials

This course will teach you the statistical display and analysis methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review.
Topic: Statistics, Biostatistics | Skill: Introductory, Intermediate | Credit Options: CEU
Class Start Dates: Apr 24, 2020, Apr 24, 2021

Additional Course Information

Organization of 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 Requirements

This is a 4-week course requiring 10-15 hours per week of review and study, at times of your choosing.

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.

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.

Please order a copy of your course textbook prior to course start date.

Software

This course does not have a software requirement.

Course Fee & Information

Enrollment
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.

Transfers and Withdrawals
We have flexible policies to transfer to another course or withdraw if necessary.

Group Rates
Contact us to get information on group rates.

Discounts
Academic affiliation?  In most courses you are eligible for a discount at checkout.

New to Statistics.com?  Click here for a special introductory discount code.  

Invoice or Purchase Order
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.

Options for Credit and Recognition

This course is eligible for the following credit and recognition options:

No Credit
You may take this course without pursuing credit or a record of completion.

Mastery or Certificate Program Credit
If you are enrolled in mastery or certificate program that requires demonstration of proficiency in this subject, your course work may be assessed for a grade.

CEUs and Proof of Completion
If you require a “Record of Course Completion” along with professional development credit in the form of Continuing Education Units (CEU’s), upon successfully completing the course, CEU’s and a record of course completion will be issued by The Institute upon your request.

Supplemental Information

There is no supplemental content for this course.

Miscellaneous

There is no additional information for this course.

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Independent Data Monitoring Committees in Clinical Trials
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