AUTHOR=Laws Thomas R. , Maishman Thomas C. TITLE=Considerations in the design of animal infection pilot studies JOURNAL=Frontiers in Cellular and Infection Microbiology VOLUME=12 YEAR=2022 URL=https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2022.948464 DOI=10.3389/fcimb.2022.948464 ISSN=2235-2988 ABSTRACT=
Ethical research with experimental systems (animals or humans) requires a rationale for the number of subjects to be included in a study. Standard methods for estimating sample size are not fit-for-purpose when the experimenter cannot predict the effect size/outcome with any certainty. These types of studies are often designated “pilot study”; however, there are few guidelines for sample size needed for a pilot study. Here we seek to address this issue. Concerning survival analysis it is noted that the experimenter can adjust the parameters of the experiment to improve the power. We propose that the experimenter needs to consider the “limit of interest” needed to represent an effect that the experimenter would be prepared to defend in terms of scientific or medical interest. Conventional power analysis is then used to estimate the