Statistics
The Ecker + Ecker statisticians work according to the international standards of evidence-based medicine. Analyses are carried out using SAS and R and take into account the requirements of the G-BA, the IQWiG methods papers, and the guidelines of EU HTA.
Indirect Comparisons and Meta-Analyses
In order to provide proof of evidence-based findings, indirect comparisons and meta-analyses are very important in early benefit assessments and will be in the upcoming EU HTA in order to demonstrate the additional benefit of a new pharmaceutical over the relevant comparative therapy. Ecker + Ecker provides the following:
- Analysis planning
- Systematic literature search
- Data extraction and validation
- Raw data analysis with SAS and R (e.g. adaptation of population, subgroups, operationalisation of endpoints)
- Indirect comparisons (Bucher´s method, mixed treatment comparison) and meta-analyses
- Assessing indirect comparisons
Clinical Trial Analysis for the Early Benefit Assessment
Due to specific requirements of the G-BA and IQWiG, it is often necessary to perform a reanalysis of clinical trials or part of clinical trials. Ecker + Ecker can revert to an extensive AMNOG expertise here. The services comprise:
- Reanalysis of clinical trials according to the G-BA and IQWIG requirements
- Recalculation of subgroups
- Calculation of additional benefit
- Calculation of indirect comparisons, (IPD-) meta-analyses, sensitivity analyses, matching-adjusted indirect comparisons (MAIC)
- Compiling all results for dossier submission
Statistics Trainings
Ecker + Ecker offers tailor-made expert trainings that can optionally be held either locally, in Hamburg, or online.
- Basics of biostatistics for the licensing and assessment of medicinal products
- Statistical requirements of early benefit assessment
- Special topics: e.g. indirect comparisons, meta-analysis, surrogate validation
Please contact
Dr. Christof Ecker
Phone +49 (40) 41 33 081-13