Klingebiel Thomas, Jürgens Heribert, Glauche Ingmar, Gnekow Astrid, Kandels Daniela, Woessmann Willi, Schneider Dominik T, Suttorp Meinolf
Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main.
Pediatric Hematology and Oncology, University Hospital Münster, Münster.
Klin Padiatr. 2020 May;232(3):124-135. doi: 10.1055/a-1081-1832. Epub 2020 Apr 20.
Cancer in children and adolescents under the age of 18 is rare; in 2017, approximately 2220 new cases in Germany were reported to the German Childhood Cancer Registry. The aim of the GPOH has always been to treat as many affected patients as possible in a standardized way, preferably in prospective, controlled studies. The Joint Federal Committee has also laid down this requirement in the paediatric oncology guideline. In a survey among the study chairs of the GPOH, it was determined how the number of clinical trials has changed following the amended drug legislation. In 2002, 33 therapy optimization studies (TOS) of the GPOH were open. Overall, TOS decreased from 33 in 2002 to 2 in 2017. The number of drug trials has increased to 16 by 2017 (almost 1100 patients registered). At the time, the number of clinical registries has increased to 28 with a total of more than 1800 registered patents. This observation shows that the clinical registers have taken on a new significance in paediatric oncology. Three examples are used to examine what contributions registries can make in relation to studies on the treatment of patients and to scientific progress. In summary, the experience gained so far from the examples discussed illustrates that studies and registries mutually represent a meaningful and necessary addition to the study group structure in paediatric oncology.
18岁以下儿童和青少年患癌症的情况较为罕见；2017年，德国儿童癌症登记处报告了约2220例新病例。德国儿童癌症研究组（GPOH）的目标一直是以标准化方式治疗尽可能多的受影响患者，最好是在前瞻性对照研究中进行。联邦联合委员会也在儿科肿瘤学指南中规定了这一要求。在对GPOH各研究负责人的一项调查中，确定了修订药品立法后临床试验数量的变化情况。2002年，GPOH开展了33项治疗优化研究（TOS）。总体而言，TOS从2002年的33项减少到2017年的2项。到2017年，药物试验数量增加到16项（登记患者近1100名）。当时，临床登记处数量增加到28个，登记患者总数超过1800名。这一观察结果表明，临床登记处在儿科肿瘤学中具有了新的意义。通过三个例子来考察登记处在患者治疗研究和科学进展方面可以做出哪些贡献。总之，从所讨论的例子中迄今获得的经验表明，研究和登记处相互构成了儿科肿瘤学研究组结构中有意义且必要的补充。
