International – Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national guidelines, and harmonization, as well as the challenge of assessing what is reportable and how to submit COVID-19 risk mitigation measures. She offers real-world experience on how she and her colleagues stopped and restarted recruitment in ongoing multinational clinical trials, and how those actions were reported globally. She concludes that close collaboration between sponsors, CROs, local affiliates, investigational sites, and health authorities is important in choosing strategies under challenging circumstances and when no precedent applies.

Introduction
Disruption is currently the central theme globally as communities and industries deal head-on with the COVID-19 pandemic. What was initially deemed a localized health challenge has become an unprecedented health crisis in a superconnected, globalized world. All industries have been affected by the pandemic, but pharmaceutical companies have found themselves center stage in this rapidly evolving crisis. The industry has come under increasing pressure to deliver safe, effective therapies and vaccines as quickly as possible, yet are faced with limited resources and inadequate guidance. Those who are managing ongoing and new clinical trials – already a challenge in non-pandemic circumstances – have had to navigate unknown territory to find a reasonable path forward while mitigating risks. Given that context, this article will focus on the regulatory reporting challenges for those conducting multinational clinical trials during the COVID-19 pandemic…