We find these invalidities arising not from failures of investigators to comply with standards found in contemporary drug developments but from specific weaknesses in these contemporary methodologies (36) that result in lack of definitive tests for efficacy (25). Currently, neuropsychiatric drug development and its CTs are too single-mindedly directed toward technical demonstrations of efficacy, with insufficient concerns for the mechanisms through which the drug acts, the conditions required to extract from drugs optimal benefits for humans, and the resources a practitioner will need to realize these benefits in patients. We are concerned that the present selective uses of scientific methods do not provide the necessary discipline and objectivity required for a truly translational neuropsychiatric drug development science (Fig. 4).
