The PRO Harmonization Group, which

The PRO Harmonization Group, which consists of theFood and Drug Administration (FDA), International SocietyFor Pharmacoeconomics and Outcomes Research (ISPOR),the European Regulatory Issues on Quality of Life AssessmentGroup (ERIQA), and the International Society for Quality ofLife Studies (ISQOL), proposes that evaluation of clinical curative effects should contain data from physicians’ reports,physiological measures, caregivers’ reports, and PROs, whichcome solely from the patient. In the course of a disease, thereare some symptoms that can only be experienced by patients;i.e., these symptoms cannot be reflected by physical measures.In this case, the normal reference values of medicine do notequal true health; additionally, physician report data are alwaysprocessed through the subjective consciousness and may onlyinclude contents related to the physician’s concerns. What’smore, this report is limited by physicians’ knowledge and experience. Therefore, PROs play an important role in clinicalpractice, and this method is now generally accepted by expertsand patients alike. Since the publication of the draft guide fornew drug development and curative effect evaluation inFebruary 2006 [2], PROs are becoming more important in assessment of treatment outcome and in new drug registration.