Bioequivalence and Bioavailability Forum • ethics and power

ethics and power [Power / Sample Size]

posted by d_labes – Berlin, Germany, 2011-11-01 12:28 (5347 d 08:15 ago) – Posting: # 7575
Views: 9,465

Good morning Mon Capitaine,

❝ For me at the end it is more about how low the power can be before ethics committees etc will flag trials as futile.

Since I have always done sample size planning with a target power >80% I haven't seen any issue regarding this raised by an IEC/IRB in my career. Did you encounter something here?

❝ ❝ But I would not give a cut-off value as futile because I think that a target power of f.i. 0.778 is equal sufficient like 0.8.

❝ Personally, I would be inclined to think that if regulators want a 90% CI with two decimals then we should consider power in a similar strict fashion since there's an ethics perspective involved.

Didn't got your point.

❝ ❝ (...) the sensitivity analysis of sample size planning Helmut is not tired to preach every time.

❝ Yeah, that guy talks a bloody lot doesn't he?

Really. But he should change his target audience to regulatory bodies :cool:

—
Regards,

Detlew

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 powerd_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