Helmut
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Vienna, Austria,
2019-06-03 10:02

Posting: # 20313
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 ICH E8(R1) step 2b [BE/BA News]

Dear all,

the ICH Harmonised Guideline General Considerations for Clinical Trials E8(R1) is in step 2b (public consultation). For the EMA public consultation is open till 30 September 2019.

Cheers,
Helmut Schütz
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ElMaestro
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Belgium?,
2019-06-03 23:18

@ Helmut
Posting: # 20314
Views: 596
 

 ICH E8(R1) step 2b

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did they try to express with this sentence: "The retention of study subjects and the follow-up of subjects who have withdrawn from treatment are key critical to quality factors" ?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

France,
2019-06-04 04:03

@ ElMaestro
Posting: # 20316
Views: 571
 

 ICH E8(R1) step 2b

Dear ElMaestro,

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did they try to express with this sentence: "The retention of study subjects and the follow-up of subjects who have withdrawn from treatment are key critical to quality factors" ?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

I'll split them in a different direction: the draft mentions withdrawal from treatment, not withdrawal of consent. That's not the same thing, though people often mix-up the two. Most patients who want to get out of a trial (which is their absolute right at any time, as you rightly point out) just tell the investigator they no longer want to take the drug (usually because it does not work, or they get adverse events, or there are two many constraints). They don't say that they withdrawn their consent. This is not patients' language, rather the translation made by the investigator (or the CRA) to make it sound official.

The consequence is that data can still be collected regarding the patients. This is particularly important for long-term mortality trials...

Regards
Ohlbe
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