We find that investigators in neuropsychiatric drug development too often use approaches that are designed to minimize the time to regulatory approval and focus too exclusively on acquiring evidence of drug efficacy. These methods, although necessary steps to develop drugs, are inadequate within themselves to support the scientifically rigorous translation of discoveries into practice benefits and expansions of scientific knowledge and methods. We have concluded from our accumulated evidence of the errors and limitations experienced by a focus on efficacy outcomes in current neuropsychiatric drug developments that incorporation of the methodological discipline exercised in fields of science outside neuropsychiatric drug development is needed to supplement current regulatory-oriented research. Below we outline recommendations toward this goal (Fig. 3).
