Improvement of phase III psychotropic drug trials by intensive phase II work

Abstract

Phase III drug trials are expensive, time-consuming procedures that too often are a disappointment, since the evidence for drug efficacy proves marginal and unconvincing. We believe that this can be remedied by attention to numerous correctable flaws during Phase II. These multiple problems require a structural solution. The development of expert, psychopharmacologic facilities that focus on deficient areas of Phase II studies so as to develop an adequate Phase III design should prove helpful.