OBJECTIVES: Definition of target profiles for new compounds and lifecycle planning lead to clinical studies in the context of a clinical trial program. Currently subgroups of special interest such as elderly, pediatrics or females/males are normally not separately included in these research programmes, most of the times not even stratified for. The objective of this research is to analyze the inclusion of patient-relevant endpoints in special patient subgroups during the clinical trial programme which would thereafter increase the pricing opportunity of this new compound in the German market. METHODS: New oncology therapies which were authorized by the European Medicine Agency (EMA) after January 1 2011 were included and assessed with respect to their evidence for special subgroups. Regulatory guidelines were compared against the IQWIG evaluation methods with respect to the handling of subgroups and its impact on the clinical benefit assessment. Furthermore GBA decisions and potential price impact with the GKV-Spitzenverband are taken into account for the pricing impact of new evidence with special subgroups based on target profiles developed. RESULTS: Overall ten new compounds were approved by the EMA in the last 2.5 years for which no subgroup trials were presented. Regulatory guidelines and IQWIG methods differ significantly with respect to subgroup handling from a statistical and health policy perspective. Most important clinical trials with a special focus on subgroups of interest could even have a negative outcome on the market access of such a compound with respect to subgroup-only reimbursement (in case of positive subgroup results) or exclusion of subgroups (in case of negative results) based on target profiles included in the analyses. CONCLUSIONS: Incentives from a health policy and investment decision perspective are low for the pharmaceutical industry in terms of research focus towards subgroups of special interest. Further research with respect to incentives is needed.