CLINICAL-PHARMACOLOGY AND CLINICAL-TRIALS IN JAPAN

Clinical pharmacology is the pursuit of rational therapeutics by follo wing the scientific principles of medicine and pharmacology. In Japan the roles for clinical pharmacology and clinical pharmacologists have been evolving since the discipline appeared in the 1950s. Clinical pha rmacology and clinical trials for drug development depend on each othe r, and clinical pharmacologists play an important role in drug develop ment in Japan. As the discipline becomes more important and complicate d, many issues regarding drug therapeutics and clinical trials in Japa n have been raised, and several points of view have been expressed. Th e following suggestions have been made to improve clinical pharmacolog y in Japan: (a) Medical education in the field of clinical pharmacolog y must be improved by creating or improving clinical pharmacology prog rams in medical schools. (b) The appropriate infrastructure for clinic al trials must be established so that the physicians' workload is redu ced, and patients' participation in clinical trials becomes much easie r. (c) Scientific and ethical standards of the pharmaceutical industry must be improved, and the effort should be made to produce drugs with new mechanisms of action or with significant expected benefits. (d) T he regulatory agency must provide stronger support, encompassing all t he various points of view of academic institutes and the pharmaceutica l industry. In light of the enthusiasm demonstrated by the government, physicians, and pharmaceutical industry in Japan for continued progre ss in clinical pharmacology, it seems likely that all its challenges w ill be overcome in the near future. Hence, despite the various problem s discussed here the future seems promising for the continued developm ent of clinical pharmacology.