Bioequivalence and Bioavailability Forum • When does power become unethical?

When does power become unethical? [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-11-02 13:01 (5353 d 06:28 ago) – Posting: # 7583
Views: 9,526

Dear Dr_Dan,

❝ I do not really understand this discussion. Is there really a need for setting a limit for the prospective power of a study?

❝ A) The prospective power is based on an assumption of an intra-subject variability. As you know the CV% varies from study to study and you will never find the one and only information that for elmaestromycin the true CV is 23.765%.

Yes. And you'll be completely hallucinated after 5 mg.

❝ B) From the sponsorś perspective why should I ask for further restrictions?

I agree that it is often a good idea to avoid complications.

❝ C) Where is the scientific basis telling you that a prospective power of 69% is futile and a power of 71% is reasonable? When does power become unethical?

There isn't any scientific justification for a limit as far as I know. This is like the 5% significance limit commonly accepted in statistics, or the 100 km/hr speed limit on Danish high ways, or the 80%-125% BE acceptance range, or the limits for cucumber curvature. They are arbitrary.

Best regards,
EM.

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 power Dr_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