What I am missing.... [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-03-29 09:26 (134 d 00:48 ago) – Posting: # 21307
Views: 903

Hi Captain,


» This is all about what Sponsors should do in this situation.
» Now, where's information on what regulators should do?

Very clever, you have turned the arrow!!! You are right, I totally agree with you, the jurisdictions bodies should circulate informations, assessment principles & rules how they will treated the conducted and submitted Clinical trials in Coronavirus situations.


» A negative scenario is if a trial is so affected by the Corona virus situation that regulators after submission will not be able to use the data to form a qualified decision whether positive or negative. In such cases, in hindsight, the trial should have been terminated for futulity.

Again, I agree with you.

» Therefore, I consider it of importance that we hear from regulators not just what they think Sponsors should do, but also what they think they should do.

I think you hope too much regarding this point. As I know, regulators prefer freezing all submissions in this time, let's wait and drink tea.

Cheers,
Osama

Complete thread:

Activity
 Admin contact
20,991 posts in 4,375 threads, 1,460 registered users;
online 26 (1 registered, 25 guests [including 17 identified bots]).
Forum time: Monday 10:15 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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