This webinar will explore data monitoring committees (DMC) best practices that have emerged over the past 25 years. The emphasis will be 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 will show 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 are illustrated by actual behind-the-scenes scenarios providing a rare look at DMC practices.
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.
Who Should Attend?
Professionals involved in design, management, analysis and regulatory aspects of confirmatory clinical trials in the pharmaceutical, biotechnology and medical device industries.
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for Pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology. IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA), Raleigh (NC) and San Francisco (CA).