title: The Rockefeller University Navigation Program: a structured multidisciplinary protocol development and educational program to advance translational research.
abstract: The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty-four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality.
authors.affiliation: The Rockefeller University Center for Clinical and Translational Science, 1230 York Avenue, New York, New York, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Brassil
authors.forename: Rhonda G
authors.initials: RG
authors.lastname: Kost
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Dowd
authors.forename: Arlene M
authors.initials: AM
authors.lastname: Hurley
authors.forename: Tyler-Lauren
authors.initials: TL
authors.lastname: Rainer
authors.forename: Barry S
authors.initials: BS
authors.lastname: Coller
mesh_terms: D035843:Biomedical Research / Q000193:education / Q000458:organization & administration; D002985:Clinical Protocols; D028744:Ethics Committees, Research / Q000458:organization & administration; D006801:Humans; D009519:New York City; D057170:Translational Research, Biomedical / Q000193:education* / Q000458:organization & administration; D014495:Universities / Q000458:organization & administration
keywords: FDA; translational research; trials