ABSTRACT
In clinical trials, an independent data monitoring committee (DMC) is often established to serve as a guard for validity and integrity of an intended clinical trial (see NIH 1998, 2000; Ellenberg et al., 2002). The DMC is independent of any activities related to the clinical operation of the study, which is comprised of experienced physicians and statisticians. Depending on the study objectives and needs of the sponsor, the primary responsibility of the independent DMC include, but are not limited to, (1) ensuring the validity and integrity of the intended clinical trial, (2) performing ongoing safety monitoring, and (3) performing interim analysis for efŒcacy. An established independent DMC will perform its function and activity according to a written charter, which is usually developed and approved by the sponsor, the investigator, and the DMC. In practice, there is separate staff supporting the functions and activities of DMC. This separate staff is usually referred to as DMC support staff. The DMC support staff is responsible for performing unblinded interim analysis and presenting the results to the DMC.
