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RegisterBlind men [Two-Stage / GS Designs]
Dear Astea,
Not with the tools available in Power2Stage.
But others have done the Job for you.
Friede T., Kieser M.
Sample size adjustment in clinical trials for proving equivalence
Drug Information Journal, Vol. 35, pp. 1401–1408, 2001 doi:0092-8615/2001
Citing page 1407:
... the computation of the actual level of the one-sided tests can be done following the lines of Kieser and Friede (unpublished data; 2001). The basic idea is the same as in the unblinded case. However, calculations are more complex and will, therefore, be omitted here. In all situations considered in Kieser and Friede (unpublished data, 2001), the inflation of the significance level was smaller than 0.0001. Therefore, no adjustment of the nominal significance level is necessary for the two one-sided tests procedure in case of blinded sample size adjustment.
It's a little bit annoying that they reference themselves and with "unpublished data" but nevertheless ...
❝ ... But for blind studies CVaverage (that is not distinguishing treatments) is not equal to CVpooled, how to deal with it? Is there a way to prove a possibility of inflation in blind parallel studies?
Not with the tools available in Power2Stage.
But others have done the Job for you.
Friede T., Kieser M.
Sample size adjustment in clinical trials for proving equivalence
Drug Information Journal, Vol. 35, pp. 1401–1408, 2001 doi:0092-8615/2001
Citing page 1407:
... the computation of the actual level of the one-sided tests can be done following the lines of Kieser and Friede (unpublished data; 2001). The basic idea is the same as in the unblinded case. However, calculations are more complex and will, therefore, be omitted here. In all situations considered in Kieser and Friede (unpublished data, 2001), the inflation of the significance level was smaller than 0.0001. Therefore, no adjustment of the nominal significance level is necessary for the two one-sided tests procedure in case of blinded sample size adjustment.
It's a little bit annoying that they reference themselves and with "unpublished data" but nevertheless ...
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- 2-stage design with interim sample size estimation d_labes 2010-10-05 15:09 [Two-Stage / GS Designs]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 2-stage design with interim sample size estimation Jack 2010-10-25 18:20
- Null = bioINequivalence Helmut 2010-10-25 19:16
- 2-stage design with interim sample size estimation d_labes 2010-10-26 13:28
- 2-stage design with interim sample size estimation Jack 2010-10-26 18:26
- Blind or not, Indecisions or Decisions d_labes 2010-10-27 16:01
- Blind or not, Indecisions or Decisions Jack 2010-10-27 18:14
- Blind ? Ohlbe 2010-10-27 23:37
- Blind ? Jack 2010-10-28 10:24
- Blind 2Stage Astea 2019-05-30 10:37
- Blind 2Stage Helmut 2019-05-30 12:56
- Blind 2Stage and an elephant Astea 2019-05-31 14:36
- Which elephant? Helmut 2019-06-02 20:14
- Blind interim in parallel design? Astea 2019-06-03 01:47
- Blind mend_labes 2019-06-05 12:23
- The Blind Leading the Blind Astea 2019-06-06 00:55
- Blind mend_labes 2019-06-05 12:23
- Blind interim in parallel design? Astea 2019-06-03 01:47
- Which elephant? Helmut 2019-06-02 20:14
- Blind 2Stage and an elephant Astea 2019-05-31 14:36
- Blind 2Stage Helmut 2019-05-30 12:56
- Blind 2Stage Astea 2019-05-30 10:37
- Blind ? Jack 2010-10-28 10:24
- Blind ? Ohlbe 2010-10-27 23:37
- Blind or not, Indecisions or Decisions Jack 2010-10-27 18:14
- Blind or not, Indecisions or Decisions d_labes 2010-10-27 16:01
- 2-stage design with interim sample size estimation Jack 2010-10-26 18:26
- 2-stage design with interim sample size estimation Jack 2010-10-25 18:20
Ing. Helmut Schütz