The association between patient outcomes under two treatments (ABOUT) in cross-over trials

The association between patient outcomes under two treatments (ABOUT) in cross-over trials

Research funded by IDDI

None

In the so-called cross-over clinical trial, each patient eventually receives all treatments being compared, one at each period of time. For instance, in the simple randomized “two-treatment, two-period” cross-over clinical trial, each patient receives both a period of experimental treatment and a period of control, with the order of these two periods varying from patient to patient randomly. Therefore, researchers can measure the response of each patient to both the experimental treatment and to control. Cross-over clinical trials are usually analyzed with the aim of determining if the experimental treatment is better (or worse, sometimes) than control, and this is done by taking “an average difference” between the effects of the treatment and the control. Here, we propose to analyze responses to both experimental treatment and control in each individual patient. Our goal is to find out if the responses in individual patients are linked (if most patients tend to respond or not to respond to both treatment and control) or whether they are independent (if the response of most patients is a random event with a probability that depends on the treatment type). Depending on our findings, future medical studies may use our results in order to decide on the most appropriate assumptions for some types of statistical analyses.

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