Mitigating Study Risk With Performance Analytics

By Jenna Rouse, Chief Experience Officer at Pro-ficiency

Increasingly, both sponsors and research sites are turning to various types of performance metrics to support risk-based management of clinical trials. But collecting and analyzing performance data after a trial has begun may not be the best approach; if data on site and researcher performance can be collected and analyzed while they are being trained on a protocol, for instance, sponsors have an opportunity to head off key risks before the first patient is enrolled in a study.

The research industry has been paying closer attention to use of performance analytics to improve the way trials are conducted. In 2017, for instance, ACRP launched an initiative with CRO Analytics[1]  to provide insight on performance analytics and how they might improve clinical research, including reductions in costs and shorter timelines.

Avoiding problems that put data at risk or cause adverse events, which could undermine a study; this requires vigorous risk management, or “the exercise of thinking in advance about study risks and implementing mitigation strategies,” Dawn Niccum, executive director of QA and compliance at inSeption Group, said in a 2021 issue of Bioprocess Online[2] . “It demands stakeholders identify critical study processes and calculate risk associated with those processes.”