CLINICAL-TRIALS OF NEW ANTIBIOTICS IN CHILDREN IN JAPAN

Japan is the most advanced of the industrialized nations in the develo pment of antibiotics. Compared to the United States and countries of t he European Union, there is a rich selection and availability of new a nd appropriate antibiotics for patients with infectious diseases in Ja pan that is unchallenged under a medical system where its people are a ll covered by a national health insurance plan. This can also be said in the area of antimicrobial treatment of children and newborns. In Ja pan, the turning point (T-point), which the author defines as the poin t when the average life expectancy of newborns equals that of 1 year o lds, was in 1970. Keeping infant deaths from infectious diseases under control was indispensable for this achievement, to which antibiotics had greatly contributed. After the T-point, another methodology was ne eded in pediatrics. The situation in Japan, where most newly developed antibiotics are equipped with statements concerning methods of admini stration, dosage and safety for children or newborns, differs consider ably from overseas situations. The procedures and methods of the clini cal trials on children that were performed in strict compliance with g ood clinical practice are described. Trial studies cannot be performed easily in Japan. Next, the reason why the clinical trials of the anti biotics in pediatrics were performed and accurately evaluated without incident over 50 years by comparatively small numbers of specialists a nd facilities is described historically and retrospectively. During th e 30 years since modern methods were established, clinical trials of a ntibiotics with children and newborns have been performed only on esse ntial agents; about one-half and one-third, respectively, of the 91 ne w antibiotics on which clinical trials with adults were conducted. The author has recently published evaluation criteria for clinical studie s on antibiotics in the pediatric field. In addition, as the trial's d irector/administrator, the author states his concept for future clinic al development of new antibiotics for children.