open-label BE trials maintain blindness [Study Per­for­mance]

posted by kimhuang – China, 2023-10-15 02:56 (243 d 14:40 ago) – Posting: # 23756
Views: 2,037

Dear ElMaestro,

reply as follows:

❝ 1. Who do you want to keep blind and why? Monitor, PI, bioanalytical staff, QA, sponsor, PK staff, statistics staff, pharmacy staff, clinical staff etc?

Per protocol, bioanalytical staff is blinded,others is not mentioned in protocol, but study team discuss PK parameters (without treatment assignment,such as Pre-dose concentration, abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) to decide analysis set in data review meeting before database lock.

❝ 2. Are the people who create the rand. code also the people who do NCA? is it the same people who do stats?

Another unblinded statistics create randomization list.

❝ 3. Who has access to the rand. code? I do not mean who should have access.

As it's an open-label BE study, CRF collect treatment sequence, so study team can access to the treatment assigment.

❝ 4. Do some of the staff with access to the rand. code also undertake other functions by any chance?

Reply as Q3.

Edit: Standard quotes restored; see also this post #8[Helmut]

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