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

posted by kratos – India, 2020-03-31 03:09 (183 d 08:49 ago) – Posting: # 21308
Views: 827

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
21,087 posts in 4,398 threads, 1,468 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 11:58 CEST (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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