Clinical trial interim monitoring support: requirements and implementation

AMIA Annu Symp Proc. 2007 Oct 11:926.

Abstract

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.

MeSH terms

  • Algorithms*
  • Clinical Protocols / standards
  • Clinical Trials as Topic* / methods
  • Clinical Trials as Topic* / standards
  • Humans
  • Patient Selection*