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

posted by wienui  – Germany/Oman, 2020-03-29 11:26 (1034 d 11:30 ago) – Posting: # 21307
Views: 1,630

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

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