US FDA Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
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Stephen Hahn also said the expedited approval process could be even more efficient.
Clinical Trials: Industry Navigating Alternative Ways Of Delivering Investigational Drugs During Pandemic
New approaches include delivering study drug from a clinical site directly to a patient’s house through a courier service, as well as use of drones and automated dispensing units; future trials could see a mix of delivery approaches.
Use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, the US agency's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.