open-label BE trials maintain blindness [Study Per­for­mance]

posted by dshah  – India/United Kingdom, 2023-10-17 11:25 (248 d 07:49 ago) – Posting: # 23760
Views: 2,001

Hi kimhuang!

❝ 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.

So there are no SOP w.r.t. pre-dose concentration, abnormal PK concentration, λz estimation? Generally QA goes ahead with protocol inclusion/exclusion criteria and SOP of BA.

❝ ❝ 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.

Does BA team also have access to CRF? Then how it is blinded?


Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,665 registered users;
45 visitors (0 registered, 45 guests [including 8 identified bots]).
Forum time: 19:14 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz