Clinical efficacy and safety: biostatistics

The European Medicines Agency's (EMA) scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.

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Guidelines

Adjustment for baseline covariates in clinical trials

Choice of a non-inferiority margin

Clinical trials in small populations

Data monitoring committees

Investigation of subgroups in confirmatory clinical trials

Missing data in confirmatory clinical trials

Points to consider

Application with 1. Meta-analyses; 2. One pivotal study

Multiplicity issues in clinical trials

Switching between superiority and non-inferiority

Reflection papers

Extrapolation of efficacy and safety in medicine development

Methodological issues in confirmatory clinical trials planned with an adaptive design

Need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available

Statistical methodology for the comparative assessment of quality attributes in drug development

ICH guidelines

ICH E9 Statistical principles for clinical trials

ICH E10 Choice of control group in clinical trials