Bioequivalence and Bioavailability Forum • ethics and power

ethics and power [Power / Sample Size]

posted by Dr_Dan – Germany, 2011-11-01 14:10 (5346 d 03:45 ago) – Posting: # 7576
Views: 9,405

Hi ElMaestro
Do you really think that an ethics committee will focus on the power of the study? As already said power is a question what risk of erroneous not concluding BE the sponsor is willing to accept. In other words the power of a study is the sponsorś problem. Each study protocol includes a paragraph giving a justification for the sample size. Based on this sample size estimation the ethics committee will decide if the study would be futile or not. So if the sponsor provides a reasonable explanation why to use a power less than 80% than it is up to the ethics committee to accept this explanation or not. IMHO this is the right procedure and I am strictly against a cut-off value for the power.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

When is a BE study futile? ElMaestro 2011-10-31 09:17
- When is a BE study futile? Dr_Dan 2011-10-31 09:46
  - When is a BE study futile? ElMaestro 2011-11-01 09:59
    - Power in the 2-stage design d_labes 2011-11-01 10:28
- When is a BE study futile? Dr_Dan 2011-10-31 12:55
- When is a BE study futile? Helmut 2011-10-31 14:41
  - When is a BE study futile? vinayshed 2011-11-01 05:59
- Minimum target power? d_labes 2011-11-01 10:04
  - ethics and power ElMaestro 2011-11-01 10:46
    - ethics and power d_labes 2011-11-01 11:28
      - ethics and power Ohlbe 2011-11-01 22:57
        
        ethics and power ElMaestro 2011-11-02 09:27
        
        ethics and power Ohlbe 2011-11-02 11:00
    - ethics and powerDr_Dan 2011-11-01 13:10
      - ethics and power ElMaestro 2011-11-01 13:53
        
        When does power become unethical? Dr_Dan 2011-11-02 10:55
        
        When does power become unethical? ElMaestro 2011-11-02 12:01