Related Experiment Videos
Clinical trials of new antibiotics in children in Japan
1Institute of Chemotherapy for Mother and Child, Tokyo, Japan.
Insights
Japan leads in antibiotic development, offering a wide range for infectious diseases, especially in pediatrics. This advanced antimicrobial stewardship in children and newborns is supported by rigorous clinical trials and national health insurance.
Area of Science:
- Pharmacology and Infectious Diseases
- Pediatric Clinical Trials and Drug Development
Background:
- Japan exhibits advanced antibiotic development and availability, particularly for infectious diseases, surpassing the US and EU.
- A national health insurance system facilitates access to a broad spectrum of antimicrobial treatments for all citizens.
- Significant contributions of antibiotics to controlling infant mortality and achieving the 'turning point' in life expectancy in 1970 are highlighted.
Purpose of the Study:
- To describe the unique situation in Japan regarding the development and clinical trials of antibiotics for pediatric and newborn populations.
- To explain the historical development and methodologies of pediatric antibiotic clinical trials in Japan.
- To present evaluation criteria and future concepts for pediatric antibiotic clinical development.
Main Methods:
- Retrospective and historical analysis of antibiotic clinical trial procedures in Japan.
- Description of clinical trial methodologies adhering to Good Clinical Practice (GCP) for pediatric and newborn populations.
- Analysis of the scope and scale of pediatric antibiotic trials compared to adult trials over 30 years.
Main Results:
- Most newly developed antibiotics in Japan include specific administration, dosage, and safety data for children and newborns.
- Pediatric clinical trials are conducted rigorously, though challenging to perform, focusing on essential agents.
- Over 50 years, trials have been managed by specialists, evaluating approximately half of new antibiotics for children and one-third for newborns.
Conclusions:
- Japan's approach to pediatric antibiotic development and clinical trials is distinct and highly advanced.
- The rigorous evaluation of antibiotics in children and newborns has been crucial for public health achievements.
- Established criteria and a forward-looking concept are essential for future pediatric antibiotic development.
Abstract:
Japan is the most advanced of the industrialized nations in the development of antibiotics. Compared to the United States and countries of the European Union, there is a rich selection and availability of new and appropriate antibiotics for patients with infectious diseases in Japan that is unchallenged under a medical system where its people are all covered by a national health insurance plan. This can also be said in the area of antimicrobial treatment of children and newborns. In Japan, the turning point (T-point), which the author defines as the point when the average life expectancy of newborns equals that of 1 year olds, 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 needed in pediatrics. The situation in Japan, where most newly developed antibiotics are equipped with statements concerning methods of administration, dosage and safety for children or newborns, differs considerably from overseas situation. The procedures and methods of the clinical trials on children that were performed in strict compliance with good clinical practice are described. Trial studies cannot be performed easily in Japan. Next, the reason why the clinical trials of the antibiotics in pediatrics were performed and accurately evaluated without incident over 50 years by comparatively small numbers of specialists and facilities is described historically and retrospectively. During the 30 years since modern methods were established, clinical trials of antibiotics with children and newborns have been performed only on essential agents; about one-half and one-third, respectively, of the 91 new antibiotics on which clinical trials with adults were conducted. The author has recently published evaluation criteria for clinical studies on antibiotics in the pediatric field. In addition, as the trial's director/administrator, the author states his concept for future clinical development of new antibiotics for children.