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.

Cite this paper

@article{Day2007ClinicalTI, title={Clinical trial interim monitoring support: requirements and implementation.}, author={Roger S. Day and Michael H. Davis}, journal={AMIA ... Annual Symposium proceedings. AMIA Symposium}, year={2007}, pages={926} }