Boos J
Department of Pediatric Hematology and Oncology, University of Münster, Germany.
Int J Clin Pharmacol Ther. 1998 Nov;36(11):613-20.
In the field of childhood malignancies, the last 30 years have witnessed the advance of highly effective treatment regimens and high cure rates through the clinical application of a growing number of cytotoxic agents. The therapeutic success was mainly brought about by the empirically based joint efforts of cooperative clinical trials that employed effective cytotoxic drug combinations at the threshold of maximum tolerable toxicity. Systematic clinical drug trials, however, aimed at the approval of specific substances for use in pediatric oncology have been lacking. The following presentation will try to describe briefly the various facets of the problem involved in the systematic development of drugs for childhood malignancies as is manifested in Germany today.
在儿童恶性肿瘤领域，过去30年见证了通过越来越多细胞毒性药物的临床应用，高效治疗方案的进步和高治愈率的实现。治疗上的成功主要归功于合作临床试验基于经验的共同努力，这些试验在最大耐受毒性阈值下采用有效的细胞毒性药物组合。然而，旨在批准用于儿科肿瘤学的特定物质的系统性临床药物试验一直缺乏。以下报告将试图简要描述当今德国所呈现出的、在系统性研发儿童恶性肿瘤药物过程中所涉及问题的各个方面。
