Bioequivalence and Bioavailability Forum

ethics and power [Power / Sample Size]

posted by ElMaestro  – Denmark, 2011-11-01 11:46 (5345 d 02:05 ago) – Posting: # 7573
Views: 9,470

Good morning d_labes,

very interesting, I think two of our perspectives here differ.

❝ But at the end it's a question what risk of erroneous not concluding BE the sponsor is willing to accept.

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

❝ 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.

❝ (...) 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?


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 powerElMaestro 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