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Repeated assessment of results in clinical trials of cancer treatment
Abstract
The problem of early assessment of results of clinical trials of cancer treatment is discussed, and the results of a computer simulation experiment presented. These show the extent to which repeated assessment of results before the end of a trial may invalidate the use of the usual significance tests. In typical practical situations, the use of yearly assessments and the acceptance as “significant” of a difference more than 1·96 times its standard error can increase two or threefold the probability of finding a “significant” difference where in fact no real difference exists between the treatments. This may be avoided if a more stringent criterion for significance is used in the early assessments. The results of a further set of simulation experiments are presented, where a difference in an early assessment is only considered significant if it is more than three times its standard error. This procedure enables results to be watched as a trial proceeds, but does not invalidate the use of a standard significance test to compare the final results. At the same time a small saving is achieved in the number of patients required.
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Metadata
- Authors
- Haybittle, J. L.
- Venue
- The British Journal of Radiology
- Publisher
- Oxford University Press (OUP)
- Published
- 1971-10
- Volume
- 44
- Issue
- 526
- Pages
- 793-797
- ISSN
- 0007-1285 (ISSN-L)
- 1748-880X
- OpenAlex
- W2019909594
- Cited by
- 517
- References
- 0
- FWCI
- 0.68
- Type
- journal article
- Language
- en
- Open access
- closed
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