Impact of COVID-19 on HV trials [Study Per­for­mance]

posted by kratos – India, 2020-03-31 03:09 (303 d 11:10 ago) – Posting: # 21308
Views: 930

Hi, certainly many many studies are impacted by the COVID situation.
Not the best time to initiate a new study; But does anyone have an experience where a trial had to be aborted half way ?
We completed Period 1 of a study in an Indian CRO and during the washout, the government issued a lock down, so period 2 is postponed until everything gets back to 'normalcy'.
My question here is, in case we have partial replicate study, and such a situation came up after completion of two periods, will it be acceptable to increase the washout for just the final period ? considering between period 1 and 2 we would have had a shorter washout, will this inconsistency be acceptable ?
Thanks

Complete thread:

Activity
 Admin contact
21,317 posts in 4,447 threads, 1,489 registered users;
online 11 (0 registered, 11 guests [including 5 identified bots]).
Forum time: Thursday 13:20 CET (Europe/Vienna)

Always listen to experts.
They’ll tell you what can’t be done and why.
Then do it.    Robert A. Heinlein

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5