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The Response to Treatment of Individual Patients in a Drug Trial

Published online by Cambridge University Press:  29 January 2018

Sinclair S. Sutherland
Affiliation:
Woodilee Hospital, Lenzie, Near Glasgow
Alistair E. Philip
Affiliation:
Scientific Staff, Medical Research Council, Unit for Research on the Epidemiology of Psychiatric Illness, Edinburgh University Department of Psychiatry, Edinburgh, 10
Mackenzie S. Sutherland
Affiliation:
Senior Registrar, The Ross Clinic, Cornhill Road, Aberdeen

Extract

It has been suggested by Philip (1969) that more information could be gleaned from conventional drug trials if it were possible to assess the efficacy of treatment for each patient in the trial. A method for the statistical analysis of individual response to treatment has been put forward by Philip using a modification of Ferguson's nonparametric trend analysis of correlated observations (Ferguson, 1965). Sutherland, Sutherland and Philip (1967) have described the details of a double-blind drug trial in which the efficacy of Prondol, an imipramine derivative, was compared with a standard imipramine preparation. The patients in their trial were rated on the Hamilton scale for depression (Hamilton, 1960) on admission, after two weeks' treatment and after four weeks' treatment. Since the data were not amenable to analysis by parametic methods, Mann-Whitney U tests (Siegel, 1956) were calculated to ascertain whether the change scores between rating occasions were different for the two groups of patients. This cumbersome procedure showed that there was no difference in change scores between the trial drug group and their controls for the 0–2 week and 0–4 week comparisons; there was, however, a significant tendency for the control drug group to show significantly greater change between the two week and four week assessments.

Type
Research Article
Copyright
Copyright © Royal College of Psychiatrists, 1969 

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References

Ferguson, G. A. (1965). Nonparametric Trend Analysis. Montreal: McGill University Press.Google Scholar
Hamilton, M. (1960). ‘A rating scale for depression.’ J. Neurol. Neurosurg. Psychiat., 23, 5662.Google Scholar
Philip, A. E. (1969). ‘A method for analysing assessments of symptom change.’ Brit.J. Psychiat.,Google Scholar
Siegel, S. (1956). Nonparametric Statistics for the Behavioral Sciences. New York: McGraw Hill.Google Scholar
Sutherland, M. S., Sutherland, S. S., and Philip, A. E. (1967). ‘Depressive illness—comparison of effects of Prondol (WY 3263) and imipramine.’ Clin. trials J., 4, 857–60.Google Scholar
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