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“Group effect” in BE [Surveys]

posted by Helmut Homepage - Vienna, Austria, 2017-05-27 14:07  - Posting: # 17422
Views: 3,091

Dear all,

I created an open survey to gather information about the current (and past) state of affairs. Ten questions, less than five minutes to answer. Feel free to join.
Sneak preview (what to expect) below:


Multigroup studies

Design

How do you design a multigroup study?
Pooling of data

Procedures (1/2)

Do you routinely pool data?
Pooling of data

Procedures (2/2)

Do you justify in the protocol why you consider pooling of data a valid approach?What is your justification of not using group-terms in the model?
Models

Procedures

Do you assess models recommended by the FDA?
  1. Group, Sequence, Treatment, Subject (nested within Group × Sequence), Period (nested within Group), Group-by-Sequence Interaction, Group-by-Treatment Interaction.
  2. Group, Sequence, Treatment, Subject (nested within Group × Sequence), Period (nested within Group), Group-by-Sequence Interaction.
  3. Sequence, Treatment, Period, Subject (nested within Sequence).
Do you follow the decision scheme recommended by the FDA?
  • If the G×T term in model 1 is ≥0.1, assess BE by model 2 of pooled data.
  • If the G×T term in model 1 is <0.1, assess BE by model 3 of the groups.

Models

Observations (please skip if you didn’t assess model 1)

How often did you observe a significant Group-by-Treatment interaction?
Applicability

Regulatory acceptance (protocol)

Was your approach accepted?
Applicability

Regulatory acceptance (report)

Was your approach accepted?
Problems

Deficiency letters, rejected studies, etc.

In which country / jurisdiction / with which agency did you face the most problems?

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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