Bioequivalence and Bioavailability Forum • Penalty for carelessness

Penalty for carelessness [Regulatives / Guidelines]

posted by mittyri – Russia, 2017-05-25 10:52 (2520 d 15:00 ago) – Posting: # 17412
Views: 28,791

Dear Helmut, Dear Beholder,

@Helmut

❝ ❝ Does any of our Russian members know whether the above was ever accepted? This section talks about giving in the report a justification for not performing such an analysis. Has anybody ever tried to give the justification already in the protocol? If yes, what happened? If no, why not?

I'd name the group effect as a 'penalty for carelessness'. After some hot discussions last week I understood that's what experts are waiting for since they do not want to dial back.
So some time ago (about 3 years ago) 'group' trend appeared in their mind. The experts asked after reports submission: group? group? group?
On the stage of request on report it was almost impossible to justify the model without groups. By the way now when this topic is very popular, the team who's developing the protocol should include the justification regarding absence of group effect in the model. Otherwise 'groupshot' is very likely.

@Beholder

❝ If Im not mistaken, you wrote something about such algorithm somewhere in forum but I could not find it.

Here you go

Edit: Changed to internal link; see also this post #7. [Helmut]

—
Kind regards,
Mittyri

Complete thread:

Russian «Экспертами» and their hobby Helmut 2017-04-29 00:46 [Regulatives / Guidelines]
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
  - Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
    - Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
      - Some answers Helmut 2017-05-02 01:10
        
        Some answers ElMaestro 2017-05-02 09:04
        
        Example Helmut 2017-05-02 12:35
        
        Sensitivity of term? mittyri 2017-05-02 18:29
        
        Simulations Helmut 2017-05-05 14:38
        
        loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
        
        loosing specificity due to low sensitivity Helmut 2017-05-09 00:55
        
        Loss in power Helmut 2017-05-06 17:31
        Interval between groups Helmut 2017-05-08 19:02
        
        IMP handling mittyri 2017-05-08 23:40
        
        IMP handling Helmut 2017-05-09 01:08
        
        Loss in power Helmut 2017-05-14 17:22
      - No convergence in JMP and Phoenix WinNonlin Helmut 2017-05-25 15:26
        
        Ouch?!??? ElMaestro 2017-05-25 16:24
- Russian «Экспертами» and their hobby Artem Gusev 2017-05-02 16:13
  - be careful with mixed models mittyri 2017-05-02 17:53
    - be careful with mixed models Artem Gusev 2017-05-03 11:02
  - p-value(s) in model 2 Helmut 2017-05-05 14:48
- Russian «Экспертами» following the EEU GLs Helmut 2017-05-24 20:17
  - Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
    - Penalty for carelessnessmittyri 2017-05-25 08:52
    - Russian «Экспертами» following the EEU GLs Beholder 2017-05-25 10:43
  - Russian «Экспертами» following the EEU GLs Mikalai 2018-01-04 10:43
    - Belarus = member of the EEU Helmut 2018-01-04 13:08
      - Belarus = member of the EEU Mikalai 2018-01-04 19:49
      - Trying your model for EEU mittyri 2018-01-04 22:04
        
        Trying your model for EEU Helmut 2018-01-05 00:06
        
        help us to stop it, please... Astea 2018-01-10 12:09
        
        help us to stop it, please... Beholder 2018-01-10 12:49
        regulators convinced by science? d_labes 2018-01-10 15:15
        
        regulators convinced by science? Beholder 2018-01-10 17:14
        
        Чёрт побери! d_labes 2018-01-10 18:53
        
        regulators convinced by science? Astea 2018-01-10 19:10
        
        Excuse me d_labes 2018-01-10 20:18
        
        Excuse me Astea 2018-01-10 20:38