Research on the Application of Patient-Reported Outcome to New Drug Development in Accordance with the Promotion of Patient-Centered
Kazumichi Kobayashi (Chief Researcher, Pharmaceutical and Industrial Policy Research Institute)
(No. 64: Published in March 2015)
Patient Reported Outcome (PRO), as the expression suggests, refers to "direct evaluation by patients," an extremely subjective evaluation that does not go through any process of evaluation by physicians, and has recently been attracting attention mainly in the United States and Europe.
In the past, clinical evaluation of new drugs tended to be viewed as "objective evaluation is always scientifically superior to subjective evaluation." Recently, however, with the environment surrounding patients, medicine, and society changing dramatically, the stereotypes of clinical evaluation are breaking down. Even if subjective, if a tool is validated by a common understanding (e.g., guideline approach), it is now recognized as scientifically acceptable. This, combined with the concept of patient-centered medicine, has led to a strong trend toward the active use of PROs in the clinical evaluation of new drugs, particularly in Europe and the United States.
In this research paper, we summarize what PROs are and how far they have progressed. In addition, we discuss the results of the study, their relation to future development, and the future of Japan, which has lagged behind in this field.