Biostatistics
The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Adjustment for baseline covariates in clinical trials - Scientific guideline
- Choice of a non-inferiority margin - Scientific guideline
- Clinical trials in small populations - Scientific guideline
- Data monitoring committees - Scientific guideline
- Investigation of subgroups in confirmatory clinical trials - Scientific guideline
- Missing data in confirmatory clinical trials - Scientific guideline
Points to consider
- Impact of the war in Ukraine on methodological aspects of ongoing clinical trials - Scientific guideline
- Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials - Scientific guideline
- Application with 1. Meta-analyses; 2. One pivotal study - Scientific guideline
- Multiplicity issues in clinical trials - Scientific guideline
- Switching between superiority and non-inferiority - Scientific guideline
- Extrapolation of efficacy and safety in medicine development - Scientific guideline
- Methodological issues in confirmatory clinical trials planned with an adaptive design - Scientific guideline
- Need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available - Scientific guideline
- Statistical methodology for the comparative assessment of quality attributes in drug development - Scientific guideline
- ICH E9 statistical principles for clinical trials - Scientific guideline
- ICH E10 Choice of control group in clinical trials - Scientific guideline
Questions and answers