Biometrics

Biometrics is the science of measuring on living beings and the analysis methods required for this purpose. Biometry or medical informatics in clinical studies includes all areas of statistical planning, database creation and statistical evaluation of study data.

Statistical planning includes the calculation of the number of cases and, in the case of randomised studies, the preparation of randomisation plans that can be integrated into databases, for example. Alternatively, the statistician can also enable the valid comparison of two groups in non-randomised clinical trials by statistical matching. Furthermore, biometrics also includes - in cooperation with the sponsor - the preparation of a Statistical Analysis Plan (SAP) to define the intended statistical analyses and type of evaluation (e.g. intention-to-treat analysis, per-protocol analysis).

For most database creation, the biometrician chooses an oracle-based Internet database. In addition to the creation of audit trails and differentiated role rights, this should be FDA-compliant and meet all GCP requirements. For this reason it is recommended to use certified and audited database systems such as SecuTrial®.

Most evaluations of clinical studies are carried out with the software SAS or SPSS. It is important that the evaluation objectives specified in the statistical analysis plan, including the target criteria (endpoints), are observed when implementing biometrics. The requirements of statistical analyses are usually implemented particularly consistently by professional contract research institutes (Clinical Research Organizations).