The CATIE investigations illustrate two perplexing problems faced by drug developers and clinical researchers in neuropsychiatry. Current statistical analyses cannot predict the success or failure of a treatment for an individual, which is after all the primary concern of the clinician caring for patients one at a time. Analyses of group or individual data can predict only the likely response, not the actual future response, of any individual in or outside the group (64). Comparative effectiveness trials, not regulatory-focused placebo superiority trials, will best inform the clinician about selection of one therapy from among a range of competing options. Statistical descriptions of individual CT subjects, for generalization to other individuals, depend on probabilities developed by using similarly behaved cases. Innovative individualized analyses that take into account the genetic and environmental uniqueness of each person are required to provide more useful applications of data from CTs. Until these analyses are available, the burden of disease monitoring inappropriately rests too exclusively with clinicians. We endorse the goal of drug development and CTs to move toward more extensive individual evaluation with the goal of determining how to effectively treat each patient.
