Journal
EXPERIMENTAL NEUROLOGY
Volume 270, Issue -, Pages 82-87Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.expneurol.2015.02.024
Keywords
Preclinical studies; Sample size; Power; Randomization; Multiple outcomes; False positive; Missing data
Categories
Funding
- NINDS (Thymectomy in Non-Thymomatous MG Patients on Prednisone) [U01NS42685]
- NHLB Training Grant [T32HL079888]
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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. (C) 2015 Elsevier Inc. All rights reserved.
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