The client needed to synthesise data from 9 phase III studies for submission to the German reimbursement authority (G-BA).
Numerus developed a comprehensive plan describing how to pool and analyse the data in accordance with the standards and expectations of IQWiG and executed all required analyses.
The project included major use of in-house developed SAS macros in order to create efficiencies and maintain tight timelines.
The client needed to compare patient survival on verses off drug for FDA approval in a rare disease, orphan indication.
Numerus undertook a complex survival analysis, firstly combining and consolidating data from multiple national disease registries.
The project included a feasibility (power) assessment, study protocol, analysis plan and report.
The client wanted to demonstrate to reimbursement authorities a link between subclinical and patient-relevant outcomes.
Numerus undertook a large network meta-analysis (NMA) linking outcomes via cutting-edge statistical procedures.
The project included feasibility assessment, analysis plan, systematic literature review (SLR) support and data extraction.
The client wished to compare their drug versus competitors in a real-world environment, on QoL and health-resource outcomes.
Numerus undertook an indirect treatment comparison (ITC), using two large German-based disease registries.
The project included developing the analysis plan, data analysis, report and peer-reviewed publication support.
The client wanted to demonstrate additional benefit over current marketed products for submission to the Canadian and French reimbursement authorities with respect to patient-relevant outcomes.
Numerus undertook an extensive network meta-analysis (NMA), which included linking more than 40 different treatment regimens.
This project concluded with 3 matching-adjusted indirect comparisons (MAICs) following a feasibility assessment analysis plan, SLR support and data extraction.