[Role of multicenter study groups for clinical research in hematology and oncology].
During the past 25 years a highly effective infrastructure for clinical trials was developed in hematology. Following initial funding by the BMFT (Ministry for Research and Technology) a number of large multicenter study groups for leukemia and lymphoma were developed. Treatment results from these studies often represent the"gold standard". However, since no standard therapy is defined for these diseases, the study groups aim to treat all patients within treatment optimization trials (TOT) to combine research and care. They contribute considerably to quality control in therapy and diagnostics, e.g., by establishing central reference laboratories. The regulatory requirements for clinical trials were extended considerably after the activation of the 12th drug law and TOTs now have to fulfill requirements similar to registration trials in the pharmaceutical industry. Due to the considerable bureaucratic effort and increased costs, only few large multicenter trials could thereafter be initiated and a substantial disadvantage for independent academic research becomes clearly evident.
Gökbuget
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Klinikum der Goethe Universität, Zentrum der Inneren Medizin, Medizinische Klinik II, Theodor Stern Kai 7, 60590, Frankfurt. goekbuget@em.uni-frankfurt.de
Hoelzer
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D
D019985:Benchmarking / Q000941:ethics / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D005858:Germany; D006405:Hematology / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D007938:Leukemia / Q000175:diagnosis / Q000628:therapy; D008223:Lymphoma / Q000175:diagnosis / Q000628:therapy; D008495:Medical Oncology / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D009101:Multiple Myeloma / Q000175:diagnosis / Q000628:therapy; D011785:Quality Assurance, Health Care / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards