Let's talk a little bit about what we think about in terms of efficacy studies. This is what we're most often exposed to, efficacy studies. They're conducted under relatively ideal, tightly-controlled conditions, and they have high internal validity.

What do we mean by internal validity? We mean that that's the degree to which a particular study's findings are going to be true for a specific study population and a specific setting, so tightly controlled. Oftentimes, really involve deviations from what usually happens in the community and sometimes what can happen in the community. Oftentimes, you exclude folks with major comorbid conditions, not only comorbid psychiatric disorders but comorbid physical disorders.

How many studies are there of anti-depressant medications in children and adolescents who have a chronic medical condition like diabetes or asthma or epilepsy? Zero. None. We don't know. Oftentimes, these studies, or almost exclusively in these efficacy studies, there is no provision for participant choice or treatment preferences because it would certainly mess up the internal validity of the study, no doubt introduce bias. Efficacy studies are generally conducted by really specialized providers in specialty settings using manualized type of control treatments. There is this expectation that if you're part of an efficacy study, you will be compliant, and if you aren't compliant to a certain degree, we're going to kick you out. And it's free usually, and we don't think about costs and those sorts of things.

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