由美國立法經驗探討促進兒科試驗暨兒科用藥研究之合理措施

To Study the Reasonable Measures of Improving Pediatric Clinical Trials and Drug Research from the U.S. Legislation Experience

西元1968年Harry Shirkey醫生著文，謂兒童是醫療上的孤兒，至今已45年，兒童依舊是醫療上的孤兒。主要原因為兒科用藥市場有限、兒科臨床試驗的困難，藥廠在評估損益後，多選擇放棄兒科市場，不從事兒科臨床試驗。專利權利的賦予，已公認係促進研發、提升產業科技與改善人類生活和健康的必要措施；然而，專利制度未必能克盡其功。

In 1968, Dr. Harry Shirkey pointed out Children are therapeutic orphans. As to the study of approved drugs, only 25% to 30% of them included pediatric data that could be approved to indicate children’s doses, safety and efficacy on the labels. Other than that, physicians prescribe off-label drugs to children. Lack of doses and safety information causes our children exposed to severe adverse effects and sometimes receive inefficient treatment. Children are different from adults, not on the height or weight, but on the bodies, such as drug metabolism, brain development,