Establishment of a clinical trials office at a children's hospital.

Abstract

To create a clinical trials office (CTO) at a children's hospital and assess its impact. Meetings with faculty and clinical trials groups were undertaken to develop a conceptual plan for an exclusively pediatric CTO designed to be a 1-stop office for sponsors, contract research organizations, and investigators. Guiding principles, eg, use of the CTO would be voluntary and paid for on a fee-for-service basis, were defined, and a business plan was developed. The CTO opened in October 1997, offering a broad menu of services. Initial marketing efforts have been followed by steadily increasing use of the CTO, measured in a number of studies and investigators who use CTO services. Commensurate growth in CTO staffing has been required. Since the CTO's opening, the number of and revenues from industry-sponsored clinical trials performed at the hospital have been significantly greater than the pre-CTO baseline and have exceeded business plan projections. In addition, the proportion of industry-sponsored clinical research at the hospital that is administered by the CTO has expanded (now >50%). The increase in hospital revenues from industry-sponsored clinical trials has exceeded the cost of running the CTO. Studies performed by the CTO have involved a mix of general pediatric clinic/private office patients, subspecialty clinic patients, and hospitalized children. A CTO dedicated to pediatric clinical research can enhance the ability of a children's hospital to participate in the growing number of pediatric clinical trials.