News Highlights
PROMETRIKA to present at MassBio
“BDM: Current Trends and Best Practices
for Data and Safety Monitoring Boards”
Thursday, May 20 2010
12:00 pm – 2:00 pm
Current Trends and Best Practices for Data and Safety Monitoring Boards
A Joint Medical and Statistical Perspective
By Candida Fratazzi, MD - President, Boston Biotech Clinical Research (BBCR), LLC and
Miganush Stepanians, Ph.D. - President & CEO, PROMETRIKA, LLC
In 1967, the NIH advisory committee recommended the establishment of Data and Safety Monitoring Boards (DSMB) for trials with clinical outcomes. Since that recommendation, many industry sponsored trials have had DSMBs, also known as Data Monitoring Committees (DMC). In 2006, the FDA issued a guidance document that most likely will result in many more industry sponsored trials with DSMB/DMC. In this presentation, we will briefly review the history and purpose of DSMBs touching upon logistics and ethics. To examine the current trends and best practices of DSMBs from the standpoint of physicians who participate on them, we administered a questionnaire to a focus group of 18 physicians from 11 therapeutic areas. The results of the questionnaire will be presented, and best practices and common pitfalls will be discussed. We will also present a review of statistical stopping rules used by DSMBs to halt a clinical trial for overwhelming efficacy or futility, and discuss a few examples from the literature where trials have been stopped for safety concerns or a non-favorable risk-benefit profile. Finally, the ethical and statistical issues involved in stopping a study will be reviewed and discussed.
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