Managing the resource demands of a large sample size in clinical trials: can you succeed with fewer subjects?

Hernández, Adrián V; Steyerberg, Ewout W

doi:10.5694/j.1326-5377.2003.tb05238.x

Topics

Statistics, epidemiology and research design

To the Editor: Keech and Gebski recently discussed some strategies for answering randomised clinical trial (RCT) questions with fewer subjects.1 We would like to point out another alternative for addressing this important topic — adjustment for baseline characteristics.2-4

Correspondence:

1. Keech AC, Gebski V. Managing the resource demands of a large sample size in clinical trials: can you succeed with fewer subjects? Med J Aust 2002; 177: 445-447. <eMJA full text>
2. Piantadosi S. Clinical trials: a methodologic perspective. 1st ed. New York: John Wiley and Sons Inc; 1997.
3. Steyerberg EW, Bossuyt PMM, Lee KL. Clinical trials in acute myocardial infarction: Should we adjust for baseline characteristics? Am Heart J 2000; 139: 745-751.
4. Maas AIR, Steyerberg EW, Murray GD, et al. Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. Neurosurgery 1999; 44: 1286-1298.
5. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: Current practice and problems. Stat Med 2002; 21: 2917-2930.

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