Quality Management for Clinical Trials within the German Competence Network Paediatric Oncology and Haematology

Abstract

The German ‘Competence Network Paediatric Oncology and Haematology’ aims at improving the structure of paediatric oncology and haematology as a whole, focussing in particular on the quality of clinical trials and study co-ordinating centres. This comprises the following measures: (1) Employment of research and trial assistants in order to improve the quality of documentation and study management in the participating hospitals. (2) Development of an internet portal to provide medical information for non-professionals, for patients and their families as well as for health professionals. (3) The project group ‘Central Trial Support’ supports study centres during the process of writing and examining new treatment protocols so that they are in compliance with the Good Clinical Practice criteria, formal criteria, legal requirements and statutory provisions. This group currently produces a structural standardisation of study protocols and case record forms in order to improve their usability. The ‘Competence Network Malignant Lymphomas’ is a project with similar aims and will be outlined for comparison.

Rare malignant pediatric tumors registered in the German Childhood Cancer Registry 2001–2010

“…Therefore, compared to other national pediatric oncology groups, the infrastructure for rare tumors in children and adolescents is very well developed in Germany. For many entities, the integration into the network of the GPOH has already been achieved, and reporting of these patients to the GCCR proved to be beneficial .…”

“…Therefore, compared to other national pediatric oncology groups, the infrastructure for rare tumors in children and adolescents is very well developed in Germany. For many entities, the integration into the network of the GPOH has already been achieved, and reporting of these patients to the GCCR proved to be beneficial [1,3]. Nevertheless, a group of patients with rare tumors remains excluded from the diagnostic, therapeutic, and scientific network of the GPOH so far and the STEP Registry focuses in particular on these non-GPOH trial patients.…”

Prospective Multicenter Registration of Major Late Sequelae in Sarcoma Patients Using the Late Effects Surveillance System (LESS)

“…This could be due to incomplete documentation of data, as a result of the unavailability of personnel for example, or because the examinations were incompletely performed. In the large paediatric oncology centres, documentation is vastly improved by documentation assistants funded by the "Kompetenznetz Pädiatrische Onkologie und Hämatologie (KPOH)" [7,8]. This could explain the discrepancy between report form return from paediatric and from internal medicine departments.…”

Meilensteine der Gesundheitspolitik und seltene Erkrankungen

“…Es ü berleben nicht nur zunehmend mehr Patienten durch eine an das individuelle R ü ckfallrisiko adaptierte Therapie, sondern die Modalit ä ten f ü r ein krankheitsfreies Langzeit ü berleben und die Normalisierung der gesundheitsbezogenen Lebensqualit ä t sind Inhalte weiterf ü hrender klinischer Forschung [7,25] . Ü ber Jahrzehnte haben sich hierbei Strukturen f ü r die klinische Forschung etabliert, die wesentlich durch begutachtete Drittmittel oder Spenden fi nanziert sind [6,16,22,27] . Im zur ü ckliegenden Jahrzehnt sind die Rahmenbedingungen durch die Gesetzgebung direkt oder indirekt durch die Schaff ung neuer Strukturen gravierend ge ä ndert worden, wie vier Hinweise belegen: ▶ Die anhaltend defi zit ä re Finanzlage der gesetzlichen Krankenkassen hat im Jahr 2002 zur Einf ü hrung eines neuen Verfahrens zur Finanzierung der station ä ren Behandlungen und der Krankenh ä user veranlasst [1,11] .…”