Table 3.

Key considerations for preclinical animal studies

Clearly delineate an a priori hypothesis for the study and include primary and secondary outcomes

Prespecify a specific measure to assess the primary and secondary outcomes.

Attempt to employ translatable biomarkers.

Consider issues of sex, timing of treatment, and age of animals.

Determine inclusion and exclusion criteria.

Demonstrate that the therapeutic compound reaches its intended target in a sufficient concentration to ensure that the hypothesis is being tested.

Carefully design a statistical analysis plan prior to initiation of the study

Perform power analysis and sample size estimates prior to initiation of the study and take into account previously measured variability in the outcome measures.

Include randomization methods for treatment groups and blinding procedures for those doing assessments.

Include procedures for dealing with dropouts and deaths of animals in statistical analyses.

Reduce publication bias

Report both positive results and negative ones in peer-reviewed journals or other open-access format.

Report details of strain, housing, diet, dropout events and in-trial exclusions so that variables can be assessed.

As in clinical trials, report the flow of animals through the treatment plan of the study.

Indicate potential conflicts of interest and whether investigators are third-party or primary investigators invested in the hypothesis.