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Klin Padiatr 2020; 232(03): 124-135
DOI: 10.1055/a-1081-1832
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Register und Studien in der Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) – Welchen Beitrag leisten sie zum Fortschritt?

Registries and studies in the Society for Pediatric Oncology and Hematology (GPOH) – What contribution do they make to progress?
Thomas Klingebiel
1   Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main
,
Heribert Jürgens
2   Pediatric Hematology and Oncology, University Hospital Münster, Münster
,
Ingmar Glauche
3   Medical Faculty „Carl Gustav Carus“, Institute for Medical Informatics and Biometry, Dresden
,
Astrid Gnekow
4   Pediatric Hematology and Oncology, University Hospital Augsburg, Augsburg
,
Daniela Kandels
4   Pediatric Hematology and Oncology, University Hospital Augsburg, Augsburg
,
Willi Woessmann
5   Pediatric Hematology and Oncology, University Hospital Hamburg Eppendorf Centre of Obstetrics and Pediatrics, Hamburg
,
Dominik T. Schneider
6   Children and Adolescents, Klinikum Dortmund gGmbH, Dortmund
,
Meinolf Suttorp
7   Pediatric Hematology and Oncology, University Hospital Dresden Center of Internal Medicine, Dresden
› Author Affiliations
Further Information

Publication History

Publication Date:
20 April 2020 (online)

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Zusammenfassung

Krebserkrankungen bei Kindern und Jugendlichen unter 18 Jahren sind selten; im Jahr 2017 wurden ca. 2220 Neuerkrankungen in Deutschland an das Deutsche Kinderkrebsregister gemeldet. Ziel der GPOH war es immer, möglichst alle betroffenen Patienten standardisiert, am besten in prospektiven, kontrollierten Studien, zu behandeln. Diese Vorgabe hat auch der Gemeinsame Bundesausschuss in der Kinderonkologierichtlinie festgeschrieben. In einer Umfrage unter den Studienleitern der GPOH wurde ermittelt, wie sich nach der geänderten Arzneimittelgesetzgebung, die Zahl der klinischen Studien verändert hat. Im Jahr 2002 waren 33 Therapieoptimierungs-studien (TOS) der GPOH geöffnet. Insgesamt ist ein Rückgang der TOS von 33 im Jahre 2002 auf 2 im Jahre 2017 zu verzeichnen. Die Zahl der Arzneimittelstudien hat sich bis zum Jahr 2017 auf 16 erhöht (knapp 1100 erfasste Patienten). Zeitgleich hat sich die Zahl der klinischen Register auf 28 erhöht mit insgesamt mehr als 1800 dort erfassten Patienten. Diese Beobachtung zeigt, dass die klinischen Register eine neue Bedeutung in der pädiatrischen Onkologie bekommen haben. An 3 Beispielen wird dargelegt, welche Beiträge Register im Verhältnis zu Studien zur Behandlung der Patienten und zum wissenschaftlichen Fortschritt leisten können. Zusammengefasst verdeutlichen die bisherigen Erfahrungen aus den diskutierten Beispielen, dass Studien und Register wechselseitig eine sinnvolle und notwendige Ergänzung der Studiengruppenstruktur in der Kinderonkologie darstellen.

Abstract

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.

Schlüsselwörter

Klinische Studien - Register - Arzneimittelgesetz - pädiatrische Hämatologie und Onkologie

Key words

Clinical studies - registries - drug law - paediatric haematology and oncology

Ergänzendes Material

 

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