Protections for interim treatment comparison plus monitoring definitions seen in final FDA guidance. (DMCs/monitoring).

TORONTO -- FDA may soon end the controversy and speculation around data monitoring committees (DMCs) with a final guidance that will primarily deal with issues about whether review of data by a DMC (which are mostly paid by sponsors) would bias data, and will give a role to DMCs to monitor studies.

Susan Ellenberg, Ph.D., Director of the Office of Biostatistics and Epidemiology at the Center for Biologics, who has been overseeing the DMC effort for the entire agency, hinted at what can be expected in the upcoming guidance at the American Assn. of Pharmaceutical Scientists (AAPS) annual meeting here Nov. 12. FDA issued a draft guidance in November 2001 (See December 2001 issue, page one). However, she gave no indication when the guidance would be released.

Over the past year, concerns were raised on how the proliferation of DMCs could bias trials, in that they are designed to examine interim data comparing actives to controls. DMCs also have been called "Data Safety Monitoring Boards" and "Data Safety Monitoring Committees." FDA chose the truncated DMC for guidance purposes.

Ellenberg suggested a broad but fundamental …