ABSTRACT
Many clinical trials are conducted by "sponsors." The sponsor is typically a pharrnaceutical company but may also be a Contract Research Organization (CRO) working for the sponsor, or a government agency (e.g., NCI) or a cooperative research group (e.g., NSABP, SWOG). The pharmaceutical industry sponsor's objective generally is to get a new drug to market or to establish new applications for a marketed product. These pharmaceutical research activities are closely observed by the Food and Drug Administration (FDA), and approvals are contingent on studies that are appropriately designed and completed. Additionally, FDA regulation states that the sponsor will monitor the clinical trial [2 1 CFR 3 l2.56(a)]. The sponsor, therefore, will closely monitor the progress of a clinical trial.
