Management of Clinical Trial Agreements

Abstract

The clinical trial agreement (CTA) is a key but often underappreciated document governing the relationship between a study site and a sponsor. Previous anecdotal materials have suggested that investigators may not often be involved in the review or negotiation of the CTA and may attach little importance to it. To provide more systematic current information, survey methods were used to explore the level of engagement, knowledge, and perceptions of investigators in the United States. The survey was distributed to more than 700 investigators—university affiliated and nonaffiliated—and/or related study staff, of whom 167 responded. Most respondents identified that they did not manage the clinical trial agreement process but were actively engaged in its review. Most were encouraged by their institutions to participate. However, some respondents expressed concerns with regard to their satisfaction with the content of the CTA, particularly with respect to issues such as financial negotiations and payments, indemnification, and subject injury language. The majority of investigators either strongly agreed or agreed that it was important for the investigator to be actively involved in the CTA process. Data from this survey provide the first systematic look at the current practices of US investigators, possible issues, and areas for improvement from the investigator’s point of view.