Interim Data Sharing by Data Safety Monitoring Board: What to share, with whom, and why
Dr. Lehana Thabane, Professor, Health Research Methods, Evidence, and Impact
Principal investigators and steering committees of randomized clinical trials routinely request data safety monitoring boards (DSMB) to share interim combined event rates. However, this practice can be challenging given the potential misinterpretation of the information, which can lead to biases and other unintended consequences.
Learning Objective:
To review the merits and demerits of sharing interim combined event rate by DSMBs.
macpedsrrt.ca 