BMJ  2004;329:966-968 (23 October), doi:10.1136/bmj.329.7472.966

Education and debate

Individual response to treatment: is it a valid assumption?

¹ Department of Statistics, University of Glasgow, Glasgow G12 8QQ stephen@stats.gla.ac.uk

Most drug trials assume that patients respond consistently to treatment, but the assumption is rarely tested. If patients vary randomly in their response to a drug rather than some patients never responding, searches for a genetic basis for non-response are futile

The first 150 words of the full text of this article appear below.

Introduction

Imagine a trial with 1000 representative patients, chosen from a population of patients with erectile dysfunction, until now resistant to treatment. Each is given the opportunity of trying a new treatment once. Seven hundred succeed in gaining an erection; the other three hundred fail. How should we interpret these results?

One common interpretation is that the treatment works for 70% of patients 100% of the time and for 30% of the patients 0% of the time. However, nothing in the data forbids a radically different interpretation—namely, that the treatment works in 100% of the patients 70% of the time. In the first case, ability to succeed on treatment is a permanent feature of the patient. In the second case, individual response cannot be predicted: the patients are indistinguishable from each other regarding response to treatment. They sometimes respond and they sometimes do not. Intermediate cases between these two extremes are, . . . [Full text of this article]

Examples of confusion

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