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Interim Analyses and Publication of Clinical Trials

E. S. Paykel, MD, FRCP, FRCPEd, FRCPsych
Arch Gen Psychiatry. 1986;43(6):613-613. doi:10.1001/archpsyc.1986.01800060107013
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To the Editor.—  Liebowitz et al,1 in the July 1984 issue of the Archives, published preliminary results of a double-blind trial of phenelzine, imipramine, and placebo, based on a sample of 60 patients. They indicated that the study was still under way and that final results would be based on 120 patients. In 1978, the same group published similar partial analyses of a study of imipramine and behavior therapy in phobias,2 later updated in the full sample.3,4 I am writing to question whether this practice is a good research method and to encourage further discussion.There are two objections to violating the code of not analyzing and publishing clinical trials when they are partially completed. The first is that knowledge of the results might prejudice blindness and evaluation of the remaining cases in the study. This must be a risk in the present case, in which there

REFERENCES

Liebowitz MR, Quitkin FM, Stewart JW, McGrath PJ, Harrison W, Rabkin J, Tricamo E, Markowitz JS, Klein DF:  Phenelzine vs imipramine in atypical depression: A preliminary report . Arch Gen Psychiatry 1984;;41:669-677.
Zitrin CM, Klein DF, Woerner MG:  Behavior therapy, supportive psychotherapy, imipramine, and phobias . Arch Gen Psychiatry 1978;;35:307-316.
Zitrin CM, Klein DF, Woerner MG, Ross DC:  Treatment of phobias: I. Comparison of imipramine hydrochloride and placebo . Arch Gen Psychiatry 1983;;40:125-138.
Klein DF, Zitrin CM, Woerner MG, Ross DC:  Treatment of phobias: II. Behavior therapy and supportive psychotherapy: Are there any specific ingredients? Arch Gen Psychiatry 1983;;40:139-145.
Quitkin FM, Rifkin A, Klein DF:  Monoamine oxidase inhibitors: A review of antidepressant effectives . Arch Gen Psychiatry 1979;;36:749-760.
Pocock SJ: Clinical Trials: A Practical Approach . Chichester, England, John Wiley & Sons, 1983;.

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Liebowitz MR, Quitkin FM, Stewart JW, McGrath PJ, Harrison W, Rabkin J, Tricamo E, Markowitz JS, Klein DF:  Phenelzine vs imipramine in atypical depression: A preliminary report . Arch Gen Psychiatry 1984;;41:669-677.
Zitrin CM, Klein DF, Woerner MG:  Behavior therapy, supportive psychotherapy, imipramine, and phobias . Arch Gen Psychiatry 1978;;35:307-316.
Zitrin CM, Klein DF, Woerner MG, Ross DC:  Treatment of phobias: I. Comparison of imipramine hydrochloride and placebo . Arch Gen Psychiatry 1983;;40:125-138.
Klein DF, Zitrin CM, Woerner MG, Ross DC:  Treatment of phobias: II. Behavior therapy and supportive psychotherapy: Are there any specific ingredients? Arch Gen Psychiatry 1983;;40:139-145.
Quitkin FM, Rifkin A, Klein DF:  Monoamine oxidase inhibitors: A review of antidepressant effectives . Arch Gen Psychiatry 1979;;36:749-760.
Pocock SJ: Clinical Trials: A Practical Approach . Chichester, England, John Wiley & Sons, 1983;.

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