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Registerethics and power [Power / Sample Size]
Dear El Maestro,
Yes, sure
On the other hand, there are several factors that may have influenced regulators' decision to ask for these decimals. They are clearly not purely scientific, but I can understand that regulators may need to take them into account too:
- one is the lack of transparency of some BE reports... If you have an upper limit of 125.49, and round it to 125 in the report, that's not totally fair, is it ? Maybe it is not relevant for that specific drug, but maybe the regulators may think otherwise. If they don't have that information, they can't make a clearly informed decision. As often, excess in one direction can result in excess in another direction.
- one is increased transparency of regulators decisions and the need for regulators to justify what they decide. More and more data get publicly available, in public assessment reports or through freedom of information provisions. If it becomes known publicly that product A was approved with an upper limit of 125.49 %, the manufacturer of the originator will make a hell of a noise about it, go to court, politicians will become involved, propose measures to restore public confidence in generics, and make everybody's life hell.
OK, I'm getting more and more off-topic here !
That would be clearly unethical
Best regards
Ohlbe
❝ Lastly, if regulators find it relevant to specify acceptance ranges with two decimals (125.00% instead of just 125%) then I would be able to understand why a minimum power requirement on basics of ethics could be specified similarly. This does not mean I find power with two decimals relevant or that I would be able to understand why it is necessary to specify an acceptance range with two decimals. Rather it just means I find power with to decimals just about as relevant as acceptance ranges with two decimals. You can probably read a little between the lines here, too.
Yes, sure
On the other hand, there are several factors that may have influenced regulators' decision to ask for these decimals. They are clearly not purely scientific, but I can understand that regulators may need to take them into account too:
- one is the lack of transparency of some BE reports... If you have an upper limit of 125.49, and round it to 125 in the report, that's not totally fair, is it ? Maybe it is not relevant for that specific drug, but maybe the regulators may think otherwise. If they don't have that information, they can't make a clearly informed decision. As often, excess in one direction can result in excess in another direction.
- one is increased transparency of regulators decisions and the need for regulators to justify what they decide. More and more data get publicly available, in public assessment reports or through freedom of information provisions. If it becomes known publicly that product A was approved with an upper limit of 125.49 %, the manufacturer of the originator will make a hell of a noise about it, go to court, politicians will become involved, propose measures to restore public confidence in generics, and make everybody's life hell.
OK, I'm getting more and more off-topic here !
❝ And in practice of course a study is never powered to 80.00%, because no one has yet come up with a way to include 34.173 patients (or whatever) in a study.
That would be clearly unethical
Best regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- When is a BE study futile? ElMaestro 2011-10-31 09:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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? ElMaestro 2011-11-01 09:59
- 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 powerOhlbe 2011-11-02 11:00
- ethics and power ElMaestro 2011-11-02 09:27
- ethics and power Ohlbe 2011-11-01 22:57
- 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
- When does power become unethical? Dr_Dan 2011-11-02 10:55
- ethics and power ElMaestro 2011-11-01 13:53
- ethics and power d_labes 2011-11-01 11:28
- ethics and power ElMaestro 2011-11-01 10:46
- When is a BE study futile? Dr_Dan 2011-10-31 09:46
Ing. Helmut Schütz