Data Monitoring Committees: Key Considerations for Biometric Professionals -- MBC Biostatistics & Data Management Committee

Tue, October 30 12:00 pm – 2:00 pm

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Biostatistics/Data Management

You are invited to join the MBC Biostatistics and Data Management Committee for a presentation on
"Data Monitoring Committees: Key Considerations for Biometric Professionals"

When: Tuesday October 30, 2007
Time: 12:00-2:00 PM
Where: MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA

Topic Overview: Data Monitoring Committees: Key Considerations for Biometric Professionals

More than ever before, Data Monitoring Committees are used in clinical trials to provide an independent assessment of safety, efficacy, study conduct and scientific integrity. These committees and the associated necessary procedures provide new challenges to the statistical and data management teams. For example, the most up-to-date information possible must be delivered clean and on-time, the results of event committees must be seamlessly incorporated, statistical procedures must be implemented for handling desired and unforeseen results, and great care taken regarding the management of critical information while keeping study teams unaware of accumulating results.

This session is designed to provide an overview of DMCs and their conduct, including operational, statistical and regulatory considerations. Steps to select a DMC, develop a charter and implement operational logistics will be presented. Statistical concepts regarding alpha spending, futility and other decision criteria will be discussed and evaluated. Considerations for what data are to be made available, what level of data cleaning is required and how to incorporate data from independent event review committees will be discussed. Considerations regarding study conduct, access to and the use of accruing information will be discussed and evaluated.

Level: Intermediate

Learning Objectives: At the conclusion of the session, attendees will:

Have an understanding of the regulatory framework for conducting Data Monitoring Committees
Have an understanding of the key steps to identify, constitute and conduct Data Monitoring Committees
Understand key areas to consider regarding data retrieval, cleaning and integration
Appreciate &/or understand the statistical considerations for alpha spending and success criteria, futility analysis and sample size adjustment. Understand the key issues regarding information flow from DMCs and the impact on the project team

Speakers:

Philip T. Lavin, Ph.D, Chief Executive Officer, Averion International Corp.

Joelle Lufkin, MPH. Associate Director, Clinical Trials, Synta Pharmaceuticals

We look forward to seeing you there!

Lunch will be served.
TO REGISTER:
email your name, title and company to register@massbio.org. Please include "BDM 10/30" in the subject line.
This event is free of charge and open to MBC Member companies and their employees only.

For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149.

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