Relevant Links

Societies, associations and networks

• International Society for Clinical Biostatistics
• European Federation of Statisticians in the Pharmaceutical Industry
• PSI - Statisticians in the Pharmaceutical Industry
• Dansk Selskab for Teoretisk Statistik
• FMS - Föreningen för Medicinsk Statistik
• Drug Information association
• Biostatistik Øresund

Regulatory authorities

• US Food and Drug Administration
• EMA - European Medicines Agency

Some relevant guidelines

• ICH Guidelines
• Guideline on the choice of the non-inferiority margin
• Reflection paper on methodological issues on confirmatory clinical trials with flexible design and analysis plan
• Points to consider on multiplicity issues in clinical trials
• Points to consider on application with 1. Meta-analyses; 2. One pivotal study
• Points to consider on switching between superiority And non-Inferiority
• Guideline on missing data in confirmatory clinical trials
• Points to consider on adjustment for baseline covariates
• Sundhedsøkonomiske guidelines fra International Society for Pharmacoeconomics and Outcomes Research

Other links

• Eudra