Safety Reporting In A Post-Covid World: Same Trends, Same Problems—But This Time, Greater Urgency
By Steven Beales, Senior Vice President, Scientific and Regulatory, WCG
So much remains unresolved about this so-called “new normal” era of clinical trials. But what we do know points to the need for more sophisticated approaches to safety reporting.
For example, we know the move to virtual and hybrid trials will continue—with the blessing of regulators. We also know that sites are still suffering the after effects of last year’s shutdowns, including staff shortages and a backlog of trials. They are, in a word, overwhelmed. Safety reporting shouldn’t add to this burden, but it does.
Safety reporting pointlessly burdens sites and investigators. Sponsors bombard them with safety notifications, many of which are unnecessary. Because of the sheer volume, they miss critical patient safety information. That was a problem in 2019, and it remains one in 2021. But the pandemic highlighted the urgent need for robust, fully automated safety reporting solutions.
This blog highlights areas of concern and places for improvement in clinical trials in our post-pandemic world.
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