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Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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6 Clinical Trials in Cancer
Pages 49-55

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From page 49...
... -- but can strike at any age. Regardless of age at onset, a study by the Council of Medical Directors of the National Association of State Mental Health Program Directors showed that individuals who receive treatment for a serious mental illness still die 25 years earlier than the normal population (NASMHPD, 2006)
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From page 50...
... His involvement in an NIH-sponsored trial and eventually an Institutional Review Board (IRB) led him to a career focused on national mental health policy and clinical research as the vehicle for answering questions of great importance to the field of mental health.
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From page 51...
... Drawing on his experience in randomizing thousands of patients into global clinical trials, he discussed why, in his view, trials are increasingly conducted outside the United States (see also the discussion of this issue in Chapters 3 and 4)
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From page 52...
... and global study populations. For example, given the large number of chemically similar antipsychotics on the market today, most individuals with schizophrenia in the United States have tried a number of medications to treat the disease.
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From page 53...
... Califf responded by questioning whether it is appropriate to market a new drug in the United States that has been tested on a very different patient population, for example, in Ukraine. In addition, he suggested that the solution to improving clinical research in the United States is not to move clinical trials abroad.
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From page 54...
... Both of these patients would be diagnosed with depression and yet have no symptoms in common, and both could be enrolled in a clinical trial for depression. This treatment of a heterogeneous disease as if it were homogeneous is one reason clinical research in depression struggles to distinguish among antidepressants.
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From page 55...
... Potter's research highlights the difficulties inherent in setting a severity criterion for entry into a clinical trial in which the measure of disease is subjective and easily manipulated. The result can be to introduce bias into a study and create significant statistical problems due to the skewed distribution of the patient population.
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Key Terms

  • clinical trial
  • conducting clinical
  • mental illness
  • patient population
  • global clinical

  • research organization
  • informed consent
  • consent process
  • informative clinical
  • human research

  • trials conducted
  • heterogeneous disease
  • drug development
  • study population
  • patient populations

  • depression research
  • iom study
  • move clinical
  • allows clinical
  • preapproval clinical

  • negative clinical
  • clinical investigators
  • successful clinical
  • reason clinical
  • improving clinical

  • clinical practice
  • clinical setting
  • trial setting
  • potter described
  • issues involved


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