Improvement of phase III psychotropic drug trials by intensive phase II work.
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.
Klein
D F
DF
New York State Psychiatric Institute, NY.
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D004341:Drug Evaluation / Q000379:methods / Q000592:standards*; D006801:Humans; D011613:Psychotherapy; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D012107:Research Design; D013375:Substance Withdrawal Syndrome
D011619:Psychotropic Drugs