UK Explains How To Build COVID-19 Resilience Into Trial Design
Sponsors Can Use Existing Regulatory Flexibilities To Minimize Further Disruptions
Executive Summary
The UK Medicines and Healthcare products Regulatory Agency wants clinical trial sponsors to integrate available regulatory flexibilities into normal practice so that their studies can withstand further potential disruptions from the COVID-19 pandemic.
You may also be interested in...
UK MHRA: COVID-19 To Spark Rise In Clinical Trial-Related Deviations
The UK’s Medicines and Healthcare products Regulatory Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.
EU IVD Regulation Delaying Clinical Trials Using Diagnostics
The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.