  Examinations of any experiment involving living organisms require
justifications of the need and moral defensibleness of the study. Statistical
planning, design and sample size calculation of the experiment are no less
important review criteria than general medical and ethical points to consider.
Errors made in the statistical planning and data evaluation phase can have
severe consequences on both results and conclusions. They might proliferate and
thus impact future trials-an unintended outcome of fundamental research with
profound ethical consequences. Therefore, any trial must be efficient in both a
medical and statistical way in answering the questions of interests to be
considered as approvable. Unified statistical standards are currently missing
for animal review boards in Germany. In order to accompany, we developed a
biometric form to be filled and handed in with the proposal at the local
authority on animal welfare. It addresses relevant points to consider for
biostatistical planning of animal experiments and can help both the applicants
and the reviewers in overseeing the entire experiment(s) planned. Furthermore,
the form might also aid in meeting the current standards set by the 3+3R's
principle of animal experimentation Replacement, Reduction, Refinement as well
as Robustness, Registration and Reporting. The form has already been in use by
the local authority of animal welfare in Berlin, Germany. In addition, we
provide reference to our user guide giving more detailed explanation and
examples for each section of the biometric form. Unifying the set of
biostatistical aspects will help both the applicants and the reviewers to equal
standards and increase quality of preclinical research projects, also for
translational, multicenter, or international studies.
