title: Practical Methods for Bounding Type I Error Rate with an Internal Pilot Design.
abstract: New analytic forms for distributions at the heart of internal pilot theory solve many problems inherent to current techniques for linear models with Gaussian errors. Internal pilot designs use a fraction of the data to re-estimate the error variance and modify the final sample size. Too small or too large a sample size caused by an incorrect planning variance can be avoided. However, the usual hypothesis test may need adjustment to control the Type I error rate. A bounding test achieves control of Type I error rate while providing most of the advantages of the unadjusted test. Unfortunately, the presence of both a doubly truncated and an untruncated chi-square random variable complicates the theory and computations. An expression for the density of the sum of the two chi-squares gives a simple form for the test statistic density. Examples illustrate that the new results make the bounding test practical by providing very stable, convergent, and much more accurate computations. Furthermore, the new computational methods are effectively never slower and usually much faster. All results apply to any univariate linear model with fixed predictors and Gaussian errors, with the t-test a special case.
authors.affiliation: Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Coffey
authors.affiliation: Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Kairalla
authors.affiliation: Division of Biostatistics, Department of Epidemiology and Health Policy Research, University of Florida, Gainesville, Florida, USA.
authors.forename: Keith E
authors.initials: KE
authors.lastname: Muller
keywords: Adaptive designs; Power; Sample size re-estimation