JMIR Publications

ABSTRACT

Background:

Early detection or awareness of adverse event (AE) occurrence during clinical trials is essential to ensure patient safety. Although clinical trials take advantage of innovative strategies, clinical designs, and state of the art technologies to evaluate efficacy and safety, early awareness of AE occurrences by investigators still needs to be systematically improved.

Objective:

This study aimed to build a system to promptly informs investigators when clinical trial participants make unscheduled visits to the emergency room or other departments within or hospital.

Methods:

We developed an “Adverse Event Awareness System (AEAS)” to facilitate early awareness of AE occurrence at the site level. The AEAS system makes investigators and study coordinators aware of AE occurrences promptly by sending automatic text messages when study participants make unscheduled visits to the emergency department or other clinics at our center. We established the AEAS system in July 2015 in the clinical trial management system. We compared the AE reporting timeline data of 305 AE occurrences from 74 clinical trials pre-initiative (December 2014-July 2015) and post-initiative (June 2015-July 2016).

Results:

The timeline for alerting investigators of an unscheduled patient visit (onset) was significantly shorten (Mean day: 4.222 + 13.217 vs. 0.787 + 2.247, P = 0.006). With post initiative, overall safety reporting timeline (from the onset to reporting time) was expedited significantly, from 5.435 to 1.180 days (P = <.001). Comparison of reporting time by clinical trial phase, in Phase 1, the average date for awareness to reporting and onset to reporting decreased statistically significantly from 1.04 to 0.45 and from 2.20 to 0.96, respectively. Low-risk trails (Level 1) greatly shortened the meantime in onset to awareness step, from 14.363 to 1.058 days (P =.01). Relatively, high-risk trials (Level 3) were shown a small decline in three AE report indicators (Mean days: 2.19 vs. 0.61, P = .51; SD: 10.28 vs. 1.37).

Conclusions:

The improvement of safety reporting timelines were most prominent in phase 4 or low-risk level trials. These findings suggest that an information technology driven automatic alert system effectively improves safety reporting timelines, which may enhance patient safety.