Objective: To assess the comparative effectiveness of biological medicines in rheumatoid arthritis in sufficiently similar patient populations, based on the current definitions of key outcomes.
Design: Systematic review and network meta-analysis including aggregate results from reanalysed individual patient data.
Data Sources: Clinical study reports and aggregate results from reanalyses of individual patient data on key outcomes for rheumatoid arthritis provided by study sponsors for studies conducted up to 2017, and several databases and registries from inception up to February 2017.
Background: When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment.
View Article and Find Full Text PDFObjective: • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction.
Patients And Methods: • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.