Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Time

Tue, Jun 16 9:00AM
T 22

Title

Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Abstract Summary

ORAL PRESENTATION SCHEDULED: Tuesday, June 16 in Session #1B at 12:17 - 12:22 pm Location: Exhibit Hall Poster Area (Hall A Entrance)

According to the Institute of Medicine, there are at least 1.5 million adverse drug events arising from medication errors annually in the United States leading to approximately 7000 deaths. Use of Interactive Response Technology (IRT) vendor-implemented randomization and dosing algorithms is an effective method to reduce the incidence of medication errors in the clinical trial setting. However, errors in the programming of randomization and dosing algorithms remains a risk factor leading to medication errors for subjects on a clinical trial. Regulatory agencies have maintained that it is ultimately the sponsor’s responsibility to maintain oversight of IRT vendor’s systems used in their clinical trials. To augment best practice IRT system testing and vendor oversight activities, we have developed a process which enables a sponsor to continuously monitor randomization and dosing algorithms such that the sponsor will become aware of potential IRT-caused dosing discrepancies within 24 hours of first occurrence, limiting the potential for a systematic error to impact a large number of subjects. Implementing this process represents an important step in ensuring subject safety and the validity of clinical trials.

Poster Presenter

Jason McCoy
MS,
Biostatistics Senior Manager,
Amgen Inc.
United States