Clinical trial interim monitoring support: requirements and implementation.
A clinical trial should never accrue a patient when the data collected to date indicate that this accrual could be unethical. An interim monitoring plan is a crude tool written into protocols to provide this assurance. At the University of Pittsburgh Cancer Institute, we have designed a software architecture to automate interim monitoring, acting appropriately when information required to determine whether a stopping criterion is fulfilled is missing. The design is modular and flexible.
Day
Roger S
RS
University of Pittsburgh, Pittsburgh, PA, USA.
Davis
Michael
M
D000465:Algorithms; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D006801:Humans; D018579:Patient Selection