Making Judgments About What to Report to Your DSMB

• Activity Number: 235
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biometrics Section
• Author(s): Susan Ellenberg*+
• Companies: University of Pennsylvania Perleman School of Medicine
• Keywords: clinical trial ; DSMB

Abstract

DSMBs/DMCs are a component of oversight of many clinical trials; this expert group in some sense "looks over the shoulder" of the sponsor and principal investigator and may make recommendations regarding study conduct. Some recommendations, such as early termination, have major implications for the study team; others may address straightforward quality control issues. There is often tension between a DSMB and study investigators, who may resent any suggestion that they are not carrying out the study properly, and who may fear termination of funding should the DSMB recommend that the study be closed. Such concerns may lead investigators to resist reporting data to the DSMB that could lead to unwanted recommendations. Since it is impossible for every aspect of an ongoing study to be presented at a DSMB meeting, some judgment must be exercised as to what to present; statisticians preparing such reports need to be aware of this issue as they plan the content of DSMB interim reports with their medical colleagues.