Bioequivalence and Bioavailability Forum

open-label BE trials maintain blindness [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2023-10-14 19:39 (57 d 16:46 ago) – Posting: # 23755
Views: 1,056

Hi kimhaung,

❝ How do open-label BE trials maintain blindness until the database is locked?

I had a small coughing fit reading this line

Can I ask:

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?
   
2. Are the people who create the rand. code also the people who do NCA? is it the same people who do stats?
   
3. Who has access to the rand. code? I do not mean who should have access.
   
4. Do some of the staff with access to the rand. code also undertake other functions by any chance?

Complete thread:

• open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Per­for­mance] 
  • Blinded NCA Helmut 2023-10-14 10:40
    • Blinded NCA kimhuang 2023-10-14 11:53
      • Blinded review of PK data: History… Helmut 2023-10-15 10:26
        • Blinded review of PK data: History… kimhuang 2023-10-16 00:43
  • open-label BE trials maintain blindnessElMaestro 2023-10-14 17:39
    • open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
      • open-label BE trials maintain blindness dshah 2023-10-17 09:25
        • open-label BE trials maintain blindness kimhuang 2023-10-18 00:50