Seq #287 Saturday, 12 March 2005
9:00 AM-11:00 AM Baltimore Convention Center 319, Hands-on Workshop
The Role of a Data and Safety Monitoring Board in Clinical Trials

Sponsored by: NIDCR
Description: The use of Data and Safety Monitoring Boards (DSMB) have been extensively utilized in many areas of clinical research for several years. However, in the oral health area, the oversight of clinical trials by a DSMB is a relatively new concept. The primary purposes for using a DSMB is to ensure independent oversight for patient safety and to ensure protocol compliance and data integrity. This symposium is intended to introduce oral health researchers to the DSMB concept. Toics to be covered are: the history of the use of DSMBs; the roles and responsibilities of the DSMB; the interaction between the DSMB, the investigators, and the local IRBs; and, the social, ethical, and cultural issues that should be considered in monitoring an international clinical trial
 
  9:00 AM Introductory Remarks
2641  9:05 AM History of Use of DSMBs
D.O. DIXON, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
  9:30 AM Roles and Responsibilities of a DSMB
B. HAWKINS, Johns Hopkins University, Baltimore, MD, USA
  9:55 AM Interaction of Investigators, Local IRBs, and the DSMB
B. MICHALOWICZ, University of Minnesota, Minneapolis, USA
  10:20 AM Social, Ethical, and Cultural Issues in Monitoring an International Trial
M.A. MONTEIL, University of the West Indies, Trinidad, Trinidad and Tobago
  10:45 AM Discussion

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