id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-334433-oudvxb4d	Beane, Joal D.	Conducting Clinical Trials in the Time of a Pandemic	2020-06-08		.txt	text/plain	1883	113	44	Responses to mitigate the effects of the pandemichave included: 1) thedevelopment of strategies to support research programs during unforeseen economic loss, 2)establishment of institutionalguidelines for clinical trials, 3)measures to ensure a healthy clinical research team, 4) useof innovative technologies to maintain access to clinical trials, 5) amendment of protocols to avoid costly trial closures, and 6) the strategic reopening of suspended clinical trials. Efforts to modify protocols in order to comply with the emergency public health response and the guidelines established by the FDA and IRBareencouraged.Investigators need to prioritize collection of data, focusing on the primary endpoint and important secondary endpoints to remain in compliance.Clinical protocols should be reexamined thoroughly and amendments should be made to reduce superfluous clinical visits.While many protocol changes typically required an amendment and lengthy review process, to avoid costly delays, reviews of amendments at our institution are being waived or expedited if the adjustment pertains to patient safety in the setting of COVID-19.	./cache/cord-334433-oudvxb4d.txt	./txt/cord-334433-oudvxb4d.txt