Preclinical studies using animals to study the potential of a therapeutic drug …
Preclinical studies using animals to study the potential of a therapeutic drug or strategy are important steps before translation to clinical trials. However, evidence has shown that poor quality in the design and conduct of these studies has not only impeded clinical translation but also led to significant waste of valuable research resources. It is clear that experimental biases are related to the poor quality seen with preclinical studies. In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources. We will also explore the differences between confirmatory and exploratory studies, and discuss available guidelines on preclinical studies and how to use them. This chapter, together with relevant information in other chapters in the handbook, provides a powerful tool to enhance scientific rigour for preclinical studies without restricting creativity.
Confirmation through competent replication is a founding principle of modern science. However, …
Confirmation through competent replication is a founding principle of modern science. However, biomedical researchers are rewarded for innovation, and not for confirmation, and confirmatory research is often stigmatized as unoriginal and as a consequence faces barriers to publication. As a result, the current biomedical literature is dominated by exploration, which to complicate matters further is often disguised as confirmation. Only recently scientists and the public have begun to realize that high-profile research results in biomedicine can often not be replicated. Consequently, confirmation has become central stage in the quest to safeguard the robustness of research findings. Research which is pushing the boundaries of or challenges what is currently known must necessarily result in a plethora of false positive results. Thus, since discovery, the driving force of scientific progress, is unavoidably linked to high false positive rates and cannot support confirmatory inference, dedicated confirmatory investigation is needed for pivotal results. In this chapter I will argue that the tension between the two modes of research, exploration and confirmation, can be resolved if we conceptually and practically separate them. I will discuss the idiosyncrasies of exploratory and confirmatory studies, with a focus on the specific features of their design, analysis, and interpretation.
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