[Progress due to networking structures. Challenges for the Competence Network Malignant Lymphomas in the Era of Precision Medicine]. / Fortschritt durch vernetzte Strukturen. Herausforderungen für das Kompetenznetz Maligne Lymphome im Zeitalter der Präzisionsmedizin.

The Competence Network Malignant Lymphomas (KML), founded in 1999 at the initiative of the Federal Ministry of Education and Research (BMBF), brings together interdisciplinary medical and scientific expertise in research on malignant lymphomas. The network helps to release synergies in evidence-based clinical research and contributes to the accelerated transfer of advances in knowledge gained from therapeutic studies for the health care of lymphoma patients. During the regular BMBF funding period (1999-2009) individual sub-projects were hived off, such as the Cochrane Haematological Malignancies Group (CHMG) or the Scientific Institute of Haematologists and Oncologists in Private Practice (WINHO GmbH). At the end of BMBF funding, pivotal KML projects such as the reference diagnostic panel for KML lymphoma study groups, site management support, health care management and the information and communication section could be continued in the scientific association "Kompetenznetz Maligne Lymphome e. V." which was founded in 2005. Due to the recent in-depth understanding of the molecular and genetic mechanisms of lymphomagenesis and the consequent transformation to precision medicine targeting specialised groups of patients, the KML is currently facing the challenge of developing modern study, health-care and information concepts in ever shorter periods of time.

[Focus on academic multicenter trials: impact of the German drug law on hematological/oncological therapy optimization trials]. / Akademische multizentrische Studien im Fokus: Auswirkungen der Arzneimittelgesetzgebung auf Therapieoptimierungsstudien in der Hämatologie/Onkologie.

BACKGROUND: The purpose of this study was to evaluate the effect of legal regulations for clinical trials on study centers participating in investigator-initiated trials (IITs) in the field of hematology/oncology. METHOD: Questionnaires were sent out to the heads of hematology-oncology study centers. RESULTS: Medical units participating in IITs have a good infrastructure and extensive experience in clinical trials. Depending on indication, a high proportion of patients have been treated in studies with the purpose to improve outcome. However, 35% of the responders will reduce their participation in IITs in the future due to a lack of financial support for staff involved in the extensive organizational tasks. CONCLUSIONS: The widely recognized research field in therapy optimization trials in hematology and oncology in Germany is at risk. This will have negative effects on the patients as highly sophisticated protocols will no longer be initiated in several study centers, resulting in the loss of valuable data for the improvement of patient therapy and outcome. To stop this development, legislators as well as regulatory authorities and health insurances need to make the necessary changes in the legal framework.