Reproducibility and Rigor in Animal-Based Research

Abstract

<jats:title>Abstract</jats:title> <jats:p>Increasing focus on issues of research reproducibility affords us the opportunity to review some of the key issues related in vivo research. First, we set out some key definitions, to guide the reader through the rest of the paper. Next we consider issues of epistemology, of how animal experiments lead to changes in our understanding of biomedicine and, potentially, to the development of new therapeutics. Here we consider the meaning of statistical significance; the importance of understanding whether findings have general truth; and the advances in knowledge which can result from ‘failed’ replication. Then, we consider weaknesses in the design, conduct and reporting of experiments, and review evidence for this from systematic reviews and from experimental studies addressing these issues. We consider the impact that these weaknesses have on the development of new treatments for human disease, and reflect on the response to these issues from the biomedical research community. Finally, we consider strategies for improvement including increased use of brief, pre-registered study protocols; pre-registration, open publication and open data; and the central importance of education in improving research performance.</jats:p>

Monitoring of tumor growth and vascularization with repetitive ultrasonography in the chicken chorioallantoic-membrane-assay

“…Therefore, this model can also be used in laboratories that do not have an animal experimental unit. Due to a high biological variation, animal experimentation is influenced by both genotype and environmental conditions resulting in an impaired reproducibility 62 , 63 . Standardization of experimental setup may be one way to address this problem 64 , 65 .…”

Robust Preclinical Evidence in Somatic Cell Genome Editing: A Key Driver of Responsible and Efficient Therapeutic Innovations

“…In cancer research, the pharmaceutical industry has been stressing the value of independent validation for some time in order to corroborate "promising" preclinical findings and to de-risk subsequent clinical development 29,30 . As such, these novel measures are an important factor for the safe and efficient translation of preclinical findings and the bedrock to guarantee stakeholders' confidence in preclinical studies supporting clinical translation 20,[29][30][31] and the practical feasibility of their implementation has already been demonstrated 32,33 .…”

Red Blood Cell Transfusion in Animal Models of Acute Brain Injuries: A Systematic Review Protocol

“…It will inform the design of future preclinical studies seeking to identify the optimal transfusion practice following acute brain injury including traumatic brain injury, ischemic stroke and cerebral hemorrhage. The best use and review of evidence of existing preclinical data to inform clinical research is increasingly recommended from a study design perspective [24] but also for ethical, economic and scienti c principles [26,34,35]. Evaluating the risks of bias in preclinical studies will also indicate whether strategies for research improvement are needed in this eld.…”