AN ANALYSIS OF FEDERAL AGENCIES' USE OF CLINICAL TRIAL AGREEMENTS

Abstract

This Field Project describes a study of Clinical Trial Agreements ("CTAs") and their use by Federal agencies in their acquisition of investigational agents from companies. The CTA serves as the vehicle by which the agency is able to conduct clinical studies using the supplied agent, and enumerates the obligations and restrictions on the parties relating to the study. This will be accomplished by a study of relevant literature and by a query of Federal agencies that utilize CTAs. The Project categorizes provisions found by each queried agency and compares them against responses from a previous study which queried academic medical centers. Furthermore, those provisions will be expounded upon so as to enable the reader to consider how a provision impacts the research. Studying these provisions may enable one to craft CTA that meets the desired needs of the parties while affording maximum protection to everyone who has a stake in the clinical research.