Establishment of a clinical trials office at a children's hospital.
OBJECTIVE
To create a clinical trials office (CTO) at a children's hospital and assess its impact.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Abzug
M J
MJ
Children's Hospital and Department of Pediatrics, University of Colorado School of Medicine, Denver, Colorado 80218, USA. abzug.mark@tchden.org
Esterl
E A
EA
D002497:Centralized Hospital Services / Q000191:economics / Q000458:organization & administration*; D002648:Child; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D006776:Hospitals, Pediatric / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D010561:Personnel Staffing and Scheduling; D012109:Research Support as Topic / Q000458:organization & administration*