Clinical trials and treatment effects monitoring

Abstract

Treatment effects monitoring is the act of reviewing accumulated data by treatment group to determine whether a trial should continue unaltered. That monitoring is required for any trial where there is a risk of an aggregate form of harm for subjects because of continued use of an inferior treatment or because of failure to use a superior treatment. Institutional review boards (IRBs), in deciding whether to approve such research, require that (when appropriate) there is adequate provision for monitoring the data collected to ensure the safety of subjects. The focus here is on the conditions necessary to satisfy this requirement. The conditions discussed are timeliness of the monitoring, completeness of data for monitoring, competency of monitors, and freedom of monitors to act and recommend as they deem necessary, regardless of the wishes, desires, or dictates of sponsors.