Clinical trial 2

Clinical trials in drug design

Nature Reviews Drug Discovery 5, 133-146 doi:10.1038/nrd1956


More than 50 years after the introduction of modern pharmacotherapies for schizophrenia, there remains a tremendous need for therapeutic advances. A second generation of antipsychotic drugs, introduced over the past 15 years, has provided uncertain advantages over the first-generation drugs. This paper reviews the designs of studies that evaluate the effectiveness of putative antipsychotic drugs. Data from the trials needed to achieve regulatory approval do not meet all the needs of clinicians and policy makers. Practical and large, simple trials that evaluate the comparative effectiveness of antipsychotic drugs in real-world settings can help to meet these needs once a drug has reached the market.

Author affiliations

  1. Department of Psychiatry, University of North Carolina at Chapel Hill, CB 7160, Chapel Hill, North Carolina, USA.
  2. Valeant Pharmaceuticals International, 6363 Greenwich Drive, Suite 100, San Diego, California 92122, USA.
  3. Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, Unit 4, New York, New York 10032, USA.
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