What I am missing.... [Regulatives / Guidelines]
Hi Captain,
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.
Again, I agree with you.
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.
❝ 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
Cheers,
Osama
Complete thread:
- Clinical trials in Corona (Covid-19) time. wienui 2020-03-29 07:15
- What I am missing.... ElMaestro 2020-03-29 08:46
- What I am missing....wienui 2020-03-29 09:26
- What I am missing.... ElMaestro 2020-03-29 08:46