ICH E8(R1) step 2b [BE/BA News]

posted by ElMaestro  – Belgium?, 2019-06-03 23:18  – Posting: # 20314
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Thanks Hötzi,

.....yawn.... :-D:cool::confused::-D

But hey, I see two interesting things when skimming through it:

1. On the last page they define BA and BE along the lines of FDA's own definition, and that is not the same in practice or by interpretation as the EU's definition. I wonder if they can somehow find a compromise. I think this one could get quite controversial if the right people discuss it.

2. Lines 595-598: "The statistical analysis plan should be finalised before the unblinding of study data, or in the case of an open-label study, before the conduct of the study." ??? That would make some BE-CRO's suffer a lot :-D

And what did they try to express with this sentence: "The retention of study subjects and the follow-up of subjects who have withdrawn from treatment are key critical to quality factors" ?

Subjects can withdraw and refuse follow-up discussions of any kind. So it isn't key and it isn't critical. It is by GCP's defintion nice to know, not need to know. Perhaps you can call the effort to get the withdrawal info critical, but now we're splitting hairs.

Nuff said.

I could be wrong, but...
Best regards,
ElMaestro

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