PRAGMATIC ATTITUDES IN THERAPEUTIC TRIALS

[摘要] . . . most therapeutic trials are inadequately formulated, and this from the earliest stages of their conception. Their inadequacy is basic, in that the trials may be aimed at the solution of one or other of two radically different kinds of problem: the resulting ambiguity affects the definition of the treatments, the assessment of the results, the choice of subjects and the way in which the treatments are compared . . . .Consider a trial of anti-cancer treatments in which radiotherapy alone is to be compared with radiotherapy preceded by the administration of a drug which has no effect by itself but which may sensitise the patient to the effects of radiation. Suppose the drug is to be administered over a 30-day period. The "radiotherapy alone" group may then be handled in two different ways: (a) radiotherapy may be preceded by a blank period of 30 days, so that it is instituted at the same time in each group; (b) radiotherapy may be instituted at once, thereby carrying it out at what is most probably the optimal time.Neither procedure can be said to be "better" than the other. The first allows us to compare two groups which are alike from the radiotherapy point of view and which differ solely in the presence or absence of the drug. It therefore provides an assessment of the sensitising effect of the drug and gives valuable information at a biological level. The second procedure enables us to compare two treatments under the conditions in which they would be applied in practice.

[学科分类] 儿科学