Keep The Best Sites. Protect Patient Safety. Reduce The Safety Reporting Burden

By Steven Beales, Senior Vice President, Scientific and Regulatory, WCG

In a highly competitive market, some sponsors are alienating sites and investigators by wasting their time. To reduce the burden on sites, sponsors must rethink how they manage safety reporting. Doing so also improves patient safety and enhances compliance.

Investigators must be kept informed of safety issues throughout the trial, but inundating them with unnecessary and duplicative reports is counterproductive. A review of nine years of safety reports found that 86% of all safety letters received by oncology sites were uninformative or unnecessary, 54% did not meet FDA “expectedness” criteria, and 50% did not meet FDA causality criteria.

Since 2015, trial growth has dramatically outpaced site capacity. At the same time, sites face rising protocol complexity and an increase in Phase 3 endpoints and all this was before COVID-19. Pandemic-related delays, backlogs and staff shortages exacerbated the problem.

All of this is to say that sites are stretched beyond the breaking point. And given the strong demand for sites, they don’t have to put up with an additional burden.

This blog captures some of the salient points from a recent webinar where Elena Jouravleva, PhD, Director of Regulatory for US Oncology Network, and I discussed the ways safety reporting overburdens sites.