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.
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Dispatches from a world turned upside down also include changes in drug sample distribution guidelines and further reductions in the hours of FDA’s COVID hotline.
Also, use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, FDA's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.
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.