wienui
★    

Germany/Oman,
2020-03-29 07:15
(864 d 09:43 ago)

(edited by wienui on 2020-03-29 07:30)
Posting: # 21305
Views: 1,904
 

 Clinical trials in Corona (Covid-19) time. [Regulatives / Guidelines]

Hello,

EMA released on Wednesday a new draft guideline for 4-week public consultation on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.

https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

Cheers,
Osama
ElMaestro
★★★

Denmark,
2020-03-29 08:46
(864 d 08:12 ago)

@ wienui
Posting: # 21306
Views: 1,601
 

 What I am missing....

Thanks Wienui,

» EMA released on Wednesday a new draft guideline for 4-week public consultation on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.
»
» https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf


This is all about what Sponsors should do in this situation.
Now, where's information on what regulators should do? As in: what do regulators do with trial results affected one way or another by the Corona situation? Are any rules or assessment principles relaxed or being more strictly followed? Which ones? And exactly how?

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. 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.

Pass or fail!
ElMaestro
wienui
★    

Germany/Oman,
2020-03-29 09:26
(864 d 07:32 ago)

@ ElMaestro
Posting: # 21307
Views: 1,588
 

 What I am missing....

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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