ECNP Preclinical Data Forum Network Webinar – GRADE for preclinical animal studies: translating evidence from bench to bedside

Laboratory animal studies are used in a wide range of human health related research areas. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions.

Systematic reviews (SRs) and meta-analyses are important tools to provide robust and informative summaries of these animal studies. Meta-analysis of the included studies and assessment of the level of certainty in the evidence might contribute to improving the translational probability of findings in experimental animal studies to clinical practice. They could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments.

The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used method to grade the certainty in the evidence and strength of health care recommendations, but in its current form is not suitable for preclinical animal studies.

Dr. Hooijmans presented a first draft of the GRADE approach for assessing the certainty in the evidence tailored to preclinical animal intervention studies in the context of (clinical) therapeutic interventions, and also discussed some methodological challenges.

Organized by ECNP Preclinical Data Forum Network and Hosted by Cohen Veterans Bioscience