Validation of experimental medicine methods in psychiatry: the P1vital approach and experience.

In the pharmaceutical industry deciding whether to progress a compound to the next stage of development or choosing between compounds in a development portfolio is laden with risk. This is particularly true of compounds developed to treat CNS disorders. The use of pre-clinical models in CNS drug development is well established but these models often lack predictive validity and many compounds fail when they reach the target patient group. Bridging the gap between pre-clinical CNS models and patient studies, P1vital's objective is to develop human volunteer models that will enable rapid, accurate and reliable decision making about which compounds to progress into patient trials. The research strategy of P1vital and its academic research network is to focus on science that progresses the development of clinical efficacy models. As part of this strategy P1vital established a CNS Experimental Medicine Consortium with members from both academic research and the pharmaceutical industry. This consortium is unique in that experimental medicine models initially developed through academic research are selected for further validation in a process that is managed by the Pharma members of the P1vital CNS Experimental Medicine Consortium steering (PEM) committee. The P1vital consortium is very much a work in progress. However, since its inception in 2007 the consortium has successfully delivered results from five clinical studies in four therapeutic areas namely, anxiety, cognitive disorders, schizophrenia and depression.