ICH E8(R1) step 2b [BE/BA News]

posted by Ohlbe – France, 2019-06-04 04:03  – Posting: # 20316
Views: 507

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did they try to express with this sentence: "The retention of study subjects and the follow-up of subjects who have withdrawn from treatment are key critical to quality factors" ?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 They don't say that they withdrawn their consent.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...


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