Viewpoint: Do not resurrect the two-stage procedure.

Szczegóły
Abstrakt

Tytuł:: Viewpoint: Do not resurrect the two-stage procedure.
Autorzy:: Senn S; School of Health and Related Research, Medical Statistics Group, University of Sheffield, Edinburgh, UK.
Źródło:: Pharmaceutical statistics [Pharm Stat] 2022 Jul; Vol. 21 (4), pp. 808-814.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Original Publication: Chichester, UK : Wiley, c2002-
MeSH Terms:: Bayes Theorem*
Computer Simulation ; Cross-Over Studies ; Humans
References:: Freeman P. The performance of the two-stage analysis of two-treatment, two-period cross-over trials. Stat Med. 1989;8:1421-1432.
Grizzle JE. The two-period change over design and its use in clinical trials. Biometrics. 1965;21:467-480.
Grizzle JE. Correction to Grizzle (1965). Biometrics. 1974;30:727.
Grieve AP. The two-period changeover design in clinical trials [letter]. Biometrics. 1982;38(2):517.
Hills M, Armitage P. The two-period cross-over clinical trial. Br J Clin Pharmacol. 1979;8:7-20.
Senn SJ. Statistical Issues in Drug Development. Vol 69. 3rd ed. John Wiley & Sons; 2021:616.
Senn SJ. Cross-over trials, carry-over effects and the art of self-delusion. Stat Med. 1988;7(10):1099-1101.
Grieve AP. A Bayesian analysis of the two-period crossover design for clinical trials. Biometrics. 1985;41(4):979-990.
Wang SJ, Hung HM. Use of two-stage test statistic in the two-period crossover trials. Biometrics. 1997;53(3):1081-1091.
Senn SJ. The case for cross-over trials in phase III. Stat Med. 1997;16(17):2021-2022.
Senn SJ. The AB/BA cross-over: how to perform the two-stage analysis if you can't be persuaded that you shouldn't. In: Hansen B, de Ridder M, eds. Liber Amicorum Roel van Strik. Erasmus University; 1996:93-100.
Grieve A, Senn S. Estimating treatment effects in clinical crossover trials. J Biopharm Stat. 1998;8(2):191-233. discussion 235-47.
Contributed Indexing:: Keywords: cross-over trial; error inflation; inference; pretesting
Entry Date(s):: Date Created: 20220712 Date Completed: 20220713 Latest Revision: 20220802
Update Code:: 20240105
DOI:: 10.1002/pst.2224
PMID:: 35819114
: Czasopismo naukowe

Full Text Finder

In 1989, Peter Freeman published a paper that challenged a commonly accepted approach for analyzing cross-over trials, the so-called two-stage procedure. Freeman himself recommended using the Bayesian approach of Andy Grieve. The flaws Freeman exposed were serious and led many statisticians to conclude that the procedure was unacceptable. Unfortunately, more than 30 years later, one still encounters its use. This note explains, using a simple simulation, why the two-stage procedure is, indeed, as Freeman showed unacceptable and should not be used.
(© 2022 John Wiley & Sons Ltd.)

Informacja