A wide variety of drugs prescribed by psychiatrists in Western countries are not yet available in Japan. The manufacturers of these drugs are often reluctant to conduct the expensive clinical trials required by the Japanese government for their approval; they have already incurred such expenses in other countries, and the market for psychiatric drugs in Japan can be uncertain. Moreover, the Japanese clinical trial system has many methodological problems, which the government has only now started to address. An international agreement to make the results of drug trials reciprocal among participating countries would reduce costs for governments as well as drug manufacturers.

This article describes clinical pitfalls in our concepts of what it means for an illness, diagnosis, or evaluation and treatment methods to say that they have been “tested”. This articles begins with the problems encountered in newborn testing for Krabbe Disease of the nervous system in New York State over the last few years as an example of a test that did not live up to its promise to help the society. Next, the article gives 3 examples of testing in psychiatry, 1. Psychological testing to make treatment decisions in children with depression, 2. Patient's and parents who have been told, or believe, that they have Asperger's disorder, and 3. The conclusions made about the efficacy of cognitive behavioral therapy based on clinical studies. The article's conclusion sums up these examples as reasons why we need to have a more practical and scientific approach to our understanding and implementation of tests used in our field.

While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, "partially-controlled clinical data" because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.