ClinicalTrials.gov reporting: strategies for success at an academic health center.
The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training, and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.
Duke Translational Medicine Institute, Regulatory Affairs Office, Durham, North Carolina, USA; Duke University School of Medicine, Durham, North Carolina, USA.
Erin K
EK
O'Reilly
Nancy J
NJ
Hassell
Denise C
DC
Snyder
Susan
S
Natoli
Irwin
I
Liu
Jackie
J
Rimmler
Valerie
V
Amspacher
Bruce K
BK
Burnett
Amanda B
AB
Parrish
Jelena P
JP
Berglund
Mark
M
Stacy
D000046:Academic Medical Centers; D026683:Advisory Committees; D002986:Clinical Trials as Topic; D006801:Humans; D020407:Internet; D007449:Investments; D058028:Research Report