Crossing international boundaries: implications for the Term Breech Trial Data Coordinating Centre.
The Term Breech Trial (TBT) is a multicenter, international randomized trial that compared a policy of planned cesarean section with a policy of planned vaginal birth for selected pregnancies with a fetus in breech presentation at term. The TBT involved 121 centers in 26 countries that recruited 2088 women between January 9, 1997 and April 21, 2000. This paper briefly describes the impact of broad international collaboration on data coordinating center activities, including center selection, obtaining ethics approvals, data management, center funding, and recruitment.
Hewson
Sheila A
SA
Maternal Infant and Reproductive Health Research Unit, The Centre for Research in Women's Health, University of Toronto, 790 Bay Street, 7th Floor, Toronto, Ontario, Canada. sheila.hewson@utoronto.ca
Weston
Julie
J
Hannah
Mary E
ME
D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D017751:Safety Management