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

Keech, Anthony C; Gebski, Val

doi:10.5694/j.1326-5377.2002.tb04888.x

Topics

Statistics, epidemiology and research design

In planning clinical trials, it is common to find that the calculated sample size1 (Item 7 of the CONSORT checklist; Box 1) is too large for available resources. Strategies to determine whether the trial question(s) can be answered with fewer subjects are needed. These include:

NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW.

Correspondence: enquiry@ctc.usyd.edu.au

1. Kirby A, Gebski V, Keech AC. Determining the sample size in a clinical trial. Med J Aust 2002; 177: 256-257. <eMJA full text>
2. Miettinen TA, Huttunen JK, Naukkarinen V, et al. Multifactorial primary prevention of cardiovascular diseases in middle-aged men. Risk factor changes, incidence and mortality. JAMA 1985; 254: 2097-2102.
3. Pablos-Méndez A, Barr G, Shea S. Run-in periods in randomized trials. Implications for the application of results in clinical practice. JAMA 1998; 279: 222-225.
4. Gebski V, Marschner I, Keech AC. Specifying objectives and outcomes for clinical trials. Med J Aust 2002; 176: 491-492. <eMJA full text>
5. Steering Committee of the Physicians' Health Study Research Group. Final report on the aspirin component of the on-going Physicians' Health Study. N Engl J Med 1989; 321: 129-135.
6. Simes RJ, Topol EJ, Holms DR Jr, et al. Link between the angiographic substudy and mortality outcomes in a large randomized trial of myocardial reperfusion. Importance of early and complete infarct artery reperfusion. GUSTO-I Investigators. Circulation 1995; 91: 1923-1928.

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