ThreeArmedTrials | R Documentation |
The package ThreeArmedTrials provides functions for designing
and analyzing non-inferiority or superiority trials with an active and a placebo control.
Non-inferiority and superiority are defined through the hypothesis
(\lambda_P - \lambda_E)/(\lambda_P - \lambda_R) \le \Delta
with the alternative hypothesis
(\lambda_P - \lambda_E)/(\lambda_P - \lambda_R) > \Delta
.
The parameters \lambda_E
, \lambda_R
, and \lambda_P
are associated with
the distribution of the endpoints and smaller values of \lambda_E
, \lambda_R
,
and \lambda_P
are considered to be desirable. A detailed description of these parameters
can be found in the help file of the individual functions. The margin \Delta
is between 0
and 1 for testing non-inferiority and larger than 1 for testing superiority.
A detailed discussion of the hypothesis can be found in Hauschke and Pigeot (2005).
The statistical theory for negative binomial distributed endpoint has been developed by Muetze et al. (2015).
Tobias Muetze tobias.muetze@outlook.com
Hauschke, D. and Pigeot, I. 2005. “Establishing efficacy of a new experimental treatment in the 'gold standard' design.” Biometrical Journal 47, 782–786. Muetze, T. et al. 2015. “Design and analysis of three-arm trials with negative binomially distributed endpoints.” Submitted.
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