Clinical trial results applied to management of the individual cancer patient.
The application of clinical trial results to the management of the individual cancer patient is not always straightforward. The results of a clinical trial indicate the "average" effect of an intervention, often expressed in terms of an absolute risk reduction, which is an estimate of the likelihood of benefit for a particular patient. However, within any clinical trial, there might be differences between groups of patients in underlying pathology, genetics, or biology, and some patients might benefit more from a new treatment than others. Thus, within a clinical trial, it might also be useful to group together patients with similar characteristics, and test for subgroup interaction. The test for interaction will indicate whether the magnitude of benefit differs from one prognostic subgroup to the next (a quantitative interaction). Much less common are qualitative interactions, in which a new treatment is beneficial in one subgroup but harmful in another. If the test for subgroup interaction is significant, then the effects of treatment may indeed differ between subgroups of patients, but this should be confirmed in other trials before a treatment is implemented in clinical practice.
Jatoi
Ismail
I
Department of Surgery, National Naval Medical Center and the Uniformed Services University, 4301 Jones Bridge Road, Bethesda, Maryland, 20814, USA. ismail.jatoi@us.army.mil
Proschan
Michael A
MA
D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size; D012680:Sensitivity and Specificity; D016019:Survival Analysis; D016896:Treatment Outcome