Development of novel behavioral interventions in an experimental therapeutics world: Challenges, and directions for the future.

Recently, the focus of funding mechanisms associated with clinical trials has changed to be consistent with an experimental therapeutics approach. While this approach holds considerable promise, the paradigm shift has presented challenges for behavioral trials in complex psychiatric illness such as schizophrenia, as molecular targets - the classic focus in experimental therapeutics paradigms - may not represent logical targets for many psychosocial interventions designed to treat multifaceted, multiply determined symptoms. Clear guidelines for alternate models have not been offered, leaving large numbers of clinical trials researchers unclear about how to frame their work. We address some of the challenges for behavioral interventions research, and offer guidance for the development of novel approaches to the application of a target engagement framework to behavioral clinical trials.