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Clinical trials in specific indications require the administration of rescuemedication in case a patient does not sufficiently respond to investigationaltreatment. The application of additional treatment on an as needed basis causesproblems to the analysis and interpretation of the results of these studiessince the effect of the investigational treatment can be confounded by theadditional medication. Following-up all patients until study end and capturingall data is not fully addressing the issue. We present an analysis that takescare of the fact that rescue is a study outcome and not a covariate when rescuemedication is administered according to a deterministic rule. This approachallows to clearly define a biological effect. For normally distributedlongitudinal data a practically unbiased estimator of the biological effect canbe obtained. The results are compared to an ITT analysis and an analysis on allpatients not receiving rescue.

Clinical trials with rescue medication applied according to a deterministic rule