Description Usage Arguments Details Value Author(s) References See Also Examples
Patients are randomized in three groups, patients who receive placebo in phase 1 and again in phase 2 of the study, patients who receive placebo in phase 1 and active in phase 2 and patients who receive active therapy in phase 1 and are not included in phase 2. A response criteria is determined and the phase 2 data of patients who respond in phase 1 is eliminated. Each phase is analyzed separately and the results are pooled. Calculates power or sample size as a function of the alternative hypothesis, posed in terms of response rates or effect sizes, for both binary and continuous outcomes.
1 2 |
n |
Total sample size of the study, leave as null if you want the sample size computed. |
power |
Power of the study, leave as null if you want the power computed. |
p |
A 2 by 2 matrix, |
w |
Weight for the first phase in the combined test |
placeboProp |
Proportion of patients randomized to placebo in the first phase |
drop |
The proportion of placebo non-responders that drop after the first phase |
alpha |
Significance level |
effect_size |
This is an alternative method of specifying the alternative. If it is used only p[2,1] needs to be specified. This is useful in the situation where a continuous endpoint is used and treatment response is not defined as the endpoint being greater than a constant. |
This program considers the situation in which response rates are supplied by the investigator, response is judged as by whether or not a continuous variable is greater than a constant, and the continuous variable is analyzed rather than the response variable. In this case it turns out the effect size for a comparison, where the response rates are p
and q
for placebo and active drug is qnorm(1-p)-qnorm(1-q)
.
A numeric vector with the following fields, sample size n
, Power for for the SPCD when using a dichotomous response outcome, Power for the SPCD using a continuous outcome where response is judged as a continuous variable being greater than a fixed constant, Power for a conventional design for a dichotomous variable and a continuous variable, Power for a SPCD design where the null is rejected if either the first phase or the second phase shows a significant difference. The first value is not corrected for multiple comparisons while the second uses a bonferroni correction.
David A. Schoenfeld dschoenfeld@mgh.harvard.edu
Fava, M., Evins, A. E., Dorer, D. J., and Schoenfeld, D. A. (2003). The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychotherapy and psychosomatics, 72,3, 115–127.
Tamura, R. N., & Huang, X. (2007). An examination of the efficiency of the sequential parallel design in psychiatric clinical trials. Clinical Trials, 4,4, 309-31.
1 2 |
Loading required package: nlme
Loading required package: lme4
Loading required package: Matrix
Attaching package: ‘lme4’
The following object is masked from ‘package:nlme’:
lmList
Loading required package: plyr
n SPCD_Response SPCD_Continuous
150.0000000 0.9256103 0.9890109
Conventional_Response Conventional_Continous uncorrected
0.9600764 0.9974665 0.9975607
corrected
0.9934268
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