Abstract
The concept of clinical applicability of results from randomized clinical drug trials goes beyond the concept of generalizability, that is, the extent to which a drug–drug or drug–placebo effect can be transferred to nonstudy populations and nonstudy conditions, since it focuses on the clinicians’ needs. This chapter addresses various aspects of the clinical applicability of results from trials in bipolar disorder. The approach is essayistic and based on a comprehensive selection of trial literature. The overall conclusion is that even though generalizability across all trials in bipolar disorder is either uncertain or narrow, there are ways in which these results can be reasonably applied to the various scenarios of clinical practice. It is also concluded that trials leading to regulatory drug approval are prerequisites for evidence-based drug treatment and are still needed for evaluation of newer, and hopefully more efficacious, treatments. However, there is an additional need to optimize the clinical use of our existing treatment through conducting trials that directly address clinically important issues, such as differential treatment response in various subgroups and treatment resistance.
Published Version
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