Literature DB >> 11414593

Controlling test size while gaining the benefits of an internal pilot design.

C S Coffey1, K E Muller.   

Abstract

To compensate for a power analysis based on a poor estimate of variance, internal pilot designs use some fraction of the planned observations to reestimate error variance and modify the final sample size. Ignoring the randomness of the final sample size may bias the final variance estimate and inflate test size. We propose and evaluate three different tests that control test size for an internal pilot in a general linear univariate model with fixed predictors and Gaussian errors. Test 1 uses the first sample plus those observations guaranteed to be collected in the second sample for the final variance estimate. Test 2 depends mostly on the second sample for the final variance estimate. Test 3 uses the unadjusted variance estimate and modifies the critical value to bound test size. We also examine three sample-size modification rules. Only test 2 can control conditional test size, align with a modification rule, and provide simple power calculations. We recommend it if the minimum second (incremental) sample is at least moderate (perhaps 20). Otherwise, the bounding test appears to have the highest power in small samples. Reanalyzing published data highlights some advantages and disadvantages of the various tests.

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Year:  2001        PMID: 11414593     DOI: 10.1111/j.0006-341x.2001.00625.x

Source DB:  PubMed          Journal:  Biometrics        ISSN: 0006-341X            Impact factor:   2.571


  11 in total

1.  Combining an Internal Pilot with an Interim Analysis for Single Degree of Freedom Tests.

Authors:  John A Kairalla; Keith E Muller; Christopher S Coffey
Journal:  Commun Stat Theory Methods       Date:  2010-12-01       Impact factor: 0.893

2.  Internal pilots for a class of linear mixed models with Gaussian and compound symmetric data.

Authors:  Matthew J Gurka; Christopher S Coffey; Keith E Muller
Journal:  Stat Med       Date:  2007-09-30       Impact factor: 2.373

3.  Practical Methods for Bounding Type I Error Rate with an Internal Pilot Design.

Authors:  Christopher S Coffey; John A Kairalla; Keith E Muller
Journal:  Commun Stat Theory Methods       Date:  2007       Impact factor: 0.893

Review 4.  Efficiency perspectives on adaptive designs in stroke clinical trials.

Authors:  Ken Cheung; Petra Kaufmann
Journal:  Stroke       Date:  2011-09-01       Impact factor: 7.914

Review 5.  Two-stage designs in bioequivalence trials.

Authors:  Helmut Schütz
Journal:  Eur J Clin Pharmacol       Date:  2015-01-22       Impact factor: 2.953

6.  Sample size re-estimation in a breast cancer trial.

Authors:  Erinn M Hade; David Jarjoura
Journal:  Clin Trials       Date:  2010-04-14       Impact factor: 2.486

7.  GLUMIP 2.0: SAS/IML Software for Planning Internal Pilots.

Authors:  John A Kairalla; Christopher S Coffey; Keith E Muller
Journal:  J Stat Softw       Date:  2008-11-13       Impact factor: 6.440

8.  Internal pilot design for balanced repeated measures.

Authors:  Xinrui Zhang; Keith E Muller; Maureen M Goodenow; Yueh-Yun Chi
Journal:  Stat Med       Date:  2017-11-21       Impact factor: 2.373

9.  An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

Authors:  John T Brinton; Brandy M Ringham; Deborah H Glueck
Journal:  Trials       Date:  2015-10-13       Impact factor: 2.279

Review 10.  Adaptive trial designs: a review of barriers and opportunities.

Authors:  John A Kairalla; Christopher S Coffey; Mitchell A Thomann; Keith E Muller
Journal:  Trials       Date:  2012-08-23       Impact factor: 2.279

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