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  • Nathalie Percie du Sert
General Principles of Preclinical Study Design
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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.

Subject:
Health, Medicine and Nursing
Material Type:
Reading
Provider:
Good Research Practice in Non-Clinical Pharmacology and Biomedicine
Author:
Andrew S. C. Rice
Jan Vollert
Nathalie Percie du Sert
Wenlong Huang
Date Added:
08/07/2020
A manifesto for reproducible science
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CC BY
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Improving the reliability and efficiency of scientific research will increase the credibility of the published scientific literature and accelerate discovery. Here we argue for the adoption of measures to optimize key elements of the scientific process: methods, reporting and dissemination, reproducibility, evaluation and incentives. There is some evidence from both simulations and empirical studies supporting the likely effectiveness of these measures, but their broad adoption by researchers, institutions, funders and journals will require iterative evaluation and improvement. We discuss the goals of these measures, and how they can be implemented, in the hope that this will facilitate action toward improving the transparency, reproducibility and efficiency of scientific research.

Subject:
Social Science
Material Type:
Reading
Provider:
Nature Human Behaviour
Author:
Brian A. Nosek
Christopher D. Chambers
Dorothy V. M. Bishop
Eric-Jan Wagenmakers
Jennifer J. Ware
John P. A. Ioannidis
Katherine S. Button
Marcus R. Munafò
Nathalie Percie du Sert
Uri Simonsohn
Date Added:
08/07/2020