Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design - PubMed (original) (raw)
. 1992 Sep 30;11(13):1685-704.
doi: 10.1002/sim.4780111304.
Affiliations
- PMID: 1485053
- DOI: 10.1002/sim.4780111304
Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design
L Frison et al. Stat Med. 1992.
Abstract
This paper explores the use of simple summary statistics for analysing repeated measurements in randomized clinical trials with two treatments. Quite often the data for each patient may be effectively summarized by a pre-treatment mean and a post-treatment mean. Analysis of covariance is the method of choice and its superiority over analysis of post-treatment means or analysis of mean changes is quantified, as regards both reduced variance and avoidance of bias, using a simple model for the covariance structure between time points. Quantitative consideration is also given to practical issues in the design of repeated measures studies: the merits of having more than one pre-treatment measurement are demonstrated, and methods for determining sample sizes in repeated measures designs are provided. Several examples from clinical trials are presented, and broad practical recommendations are made. The examples support the value of the compound symmetry assumption as a realistic simplification in quantitative planning of repeated measures trials. The analysis using summary statistics makes no such assumption. However, allowance in design for alternative non-equal correlation structures can and should be made when necessary.
Comment in
- Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design.
Senn S. Senn S. Stat Med. 1994 Jan 30;13(2):197-8. doi: 10.1002/sim.4780130210. Stat Med. 1994. PMID: 8122055 No abstract available. - Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design by L. Frison and S.J. Pocock, Statistics in Medicine 1992; 12: 1685-1704.
Julious SA. Julious SA. Stat Med. 2000 Nov 30;19(22):3133-5. doi: 10.1002/1097-0258(20001130)19:22<3133::aid-sim744>3.0.co;2-0. Stat Med. 2000. PMID: 11113948 No abstract available.
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