{"title":"Preclinical pilot studies: Five common pitfalls and how to avoid them.","authors":"Natasha A Karp, Alan Sharpe, Benjamin Phillips","doi":"10.1177/00236772241244519","DOIUrl":null,"url":null,"abstract":"<p><p>Pilots are small-scale initial experiments that are intended to guide the design of future, larger studies, with a view to increasing their effectiveness. In this statistical primer we highlight five common mistakes that limit the utility of pilot studies and provide practical guidance to avoid such errors and increase their effectiveness. The common thread connecting these mistakes is insufficient planning and over-interpretation of the results. This approach compromises the ultimate goals of the research programme and the future experimental cascade. In support of our view that over-interpretation is an error, we present a simple simulation to demonstrate that pilots will generally generate an inaccurate estimate of the variability of the biological endpoint under study and that frequent under-estimation will lead to inconclusive and unethical subsequent experiments. We argue that well planned pilots are an important part of the research cascade and still need to be implemented to a high standard.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Laboratory Animals","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/00236772241244519","RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/5 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"VETERINARY SCIENCES","Score":null,"Total":0}
引用次数: 0
Abstract
Pilots are small-scale initial experiments that are intended to guide the design of future, larger studies, with a view to increasing their effectiveness. In this statistical primer we highlight five common mistakes that limit the utility of pilot studies and provide practical guidance to avoid such errors and increase their effectiveness. The common thread connecting these mistakes is insufficient planning and over-interpretation of the results. This approach compromises the ultimate goals of the research programme and the future experimental cascade. In support of our view that over-interpretation is an error, we present a simple simulation to demonstrate that pilots will generally generate an inaccurate estimate of the variability of the biological endpoint under study and that frequent under-estimation will lead to inconclusive and unethical subsequent experiments. We argue that well planned pilots are an important part of the research cascade and still need to be implemented to a high standard.
期刊介绍:
The international journal of laboratory animal science and welfare, Laboratory Animals publishes peer-reviewed original papers and reviews on all aspects of the use of animals in biomedical research. The journal promotes improvements in the welfare or well-being of the animals used, it particularly focuses on research that reduces the number of animals used or which replaces animal models with in vitro alternatives.