Data Monitoring Committees (DMC) Best Practices

December 8, 2014

IDDI organized a webinar on Data Monitoring Committees (DMC) best practices.

  • This webinar explored data monitoring committees (DMC) best practices that have emerged over the past 25 years. The emphasis was on the safety monitoring responsibilities of DMCs in the pharma industry. The industry will be divided into Big Pharma, Middle Pharma and Infant Pharma.
  • The webinar showed how practices and issues vary over these three strata. From here organizational issues, meetings, clinical issues, useful statistical methods, biases and pitfalls, data monitoring committees decisions and emerging issues including adaptive designs, internal DMCs and cost control will be covered.
  • The impact of emerging Internet-based high tech vital signs and body fluid monitoring and automated risk based monitoring on DMC operations will also be covered. The issues were illustrated by actual behind-the-scenes scenarios providing a rare look at DMC practices.
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Data Monitoring Committees (DMC) Best Practices

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Contents:

  • This webinar explored data monitoring committees (DMC) best practices that have emerged over the past 25 years. The emphasis was on the safety monitoring responsibilities of DMCs in the pharma industry. The industry will be divided into Big Pharma, Middle Pharma and Infant Pharma.

Speaker:

Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA.
Dr. Herson, a collaborator of IDDI, will draw on his 25-year experience with data monitoring committees (DMC) in the pharmaceutical industry which led to his book Data and Safety Monitoring Committees in Clinical Trials published by Chapman and Hall/CRC in 2009.

Presentation of the Webinar: Data Monitoring Committees (DMC) Best Practices

To access the presentation of this on-demand webinar, please fill out this form.

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