Statistical considerations for preclinical studies

Experimental Neurology
Inmaculada B Aban, Brandon George

Abstract

Research studies must always have proper planning, conduct, analysis and reporting in order to preserve scientific integrity. Preclinical studies, the first stage of the drug development process, are no exception to this rule. The decision to advance to clinical trials in humans relies on the results of these studies. Recent observations show that a significant number of preclinical studies lack rigor in their conduct and reporting. This paper discusses statistical aspects, such as design, sample size determination, and methods of analyses, that will help add rigor and improve the quality of preclinical studies.

References

Dec 1, 1996·Journal of Neuroimmunology·S J PiddlesdenB P Morgan
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Jun 28, 2008·Seminars in Hematology·Steven Goodman
Feb 6, 2009·Annals of Neurology·Jindrich SoltysHenry J Kaminski
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Mar 29, 2014·Nature·Steve Perrin

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Citations

Mar 11, 2017·PLoS Biology·Konrad NeumannUlrich Dirnagl
Jul 14, 2016·Statistical Methods in Medical Research·Chunyan CaiXuelin Huang
Jan 23, 2019·Journal of Orthopaedic Research : Official Publication of the Orthopaedic Research Society·T Fintan MoriartyR Geoff Richards
Oct 9, 2018·Statistics in Biosciences·Chunyan CaiXuelin Huang
Dec 14, 2019·Anesthesiology·Roderic G EckenhoffMaryellen F Eckenhoff
May 24, 2020·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Sahar AwwadSteve Brocchini
Mar 25, 2021·Journal of Cerebral Blood Flow and Metabolism : Official Journal of the International Society of Cerebral Blood Flow and Metabolism·Ariel DiazManuel Yepes

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