Generation of evidence for successful market access

Statistical analyses, indirect comparisons and meta-analyses

For the approval of medicinal products, different requirements apply than in HTA and market access. This often makes further analyses or additional evaluations of clinical studies necessary. Here you can draw on the extensive methodological know-how of our statistics experts and the high quality of our statistical data. With SAS we evaluate study data according to the requirements of the Joint Federal Committee (G-BA) and the IQWiG, including subgroup analyses or additional analyses; we then insert these analyses into the dossier without errors using macros we have developed ourselves – a crucial point in view of the higher requirements of the new dossier template of the G-BA.

If the medicinal product or medical device to be evaluated has not been directly compared with a specific comparator therapy in studies, an additional benefit compared to this comparator therapy can only be shown via an indirect comparison. The method of choice is usually an adjusted indirect comparison via a bridge comparator (Bucher method). Another form of indirect comparison is network meta-analysis (mixed treatment comparison, multiple treatment meta-analysis), which is used to compare a large number of interventions with each other. These analyses are becoming increasingly important in HTA and benefit assessment due to the increasingly complex therapy landscape.

How you can benefit from our services:

  • Re-evaluation of clinical studies especially for HTA and benefit assessment
  • Statistical analysis planning and execution of indirect comparisons and network meta-analyses
  • Presentation of results for HTA and the benefit dossier according to requirements using the macros we have developed
  • Consideration of internationally recognised standards of evidence-based medicine and specifications of the Federal Joint Committee (G-BA), IQWiG and EUNetHTA
  • Transparent and complete documentation of all statistical analyses and evaluations