Background: The interpretation of subgroup analyses in clinical research is still challenging. Beside statistical criteria such as pre- or post-specification, multiplicity, power, and the applied statistical technique, the reason for conducting subgroup analyses plays a role. Moreover, the interpretation of subgroup findings may be dependent on the context in which the corresponding results are assessed.

Objectives: To discuss the effect of the assessment goal on the interpretation of subgroup analyses and the corresponding conclusions in the context of drug approval and reimbursement.

Methods: By means of an example it is discussed and demonstrated that the different perspectives of drug approval and reimbursement can lead to different conclusions regarding subgroup analyses.

Results: Noninferiority to an established drug is a plausible basis for licensing a safe new drug. However, reimbursement at higher costs requires an additional clinical benefit, which means that superior efficacy of the new drug compared to the established drug has to be demonstrated. In the situation of similar efficacy of the new and the established drug in one subgroup and superior efficacy of the new drug in a second subgroup, it would be adequate to approve the new drug for the whole population but restrict reimbursement to the second subgroup of patients.

Conclusions: Different assessment goals of different institutes or authorities may lead to different conclusions regarding subgroup analyses. The specific context of decisions has to be considered in the interpretation of the credibility and importance of subgroup findings.