The Value of Computer-Assisted Data Review in the Clinical Development Process

Two years ago, Amgen Clinical Data Management implemented a computer edit check system to detect data problems (such as data inconsistencies and missing data) in its clinical trials databases. The benefits of this system were recently evaluated on three large clinical trials databases (with a total of 156,783 case report forms) to determine its impact on operations and, in particular, on the number of staff required to perform data review and finalization activities. It was found that the use of the computer edit check system resulted in a 37.5% productivity increase. For the three clinical trials evaluated, this productivity resulted in a total of six clinical data associate staff-years saved.