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

posted by ElMaestro  – Belgium?, 2020-03-29 06:46 (210 d 10:30 ago) – Posting: # 21306
Views: 1,082

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.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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