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Bedeutung von Multicenterstudiengruppen für die klinische Forschung in der Hämatologie und Onkologie

Role of multicenter study groups for clinical research in hematology and oncology

  • Leitthema
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Auf dem Gebiet der Hämatologie wurde in den vergangenen 25 Jahren eine besonders effektive Studieninfrastruktur entwickelt. Nach einer Initialförderung durch das damalige Bundesministerium für Forschung und Technologie (BMFT) wurden große Multicenterstudiengruppen für Leukämien und Lymphome aufgebaut. Die Therapieergebnisse, die in diesen Studien erzielt wurden, sind eindrucksvoll und stellen zum Teil den „Goldstandard“ dar. Da es für den überwiegenden Teil der genannten Erkrankungen keine Standardbehandlungen gibt, wird weiterhin angestrebt, möglichst alle Patienten in Therapieoptimierungsstudien (TOS) zu behandeln und so Versorgung und Forschung miteinander zu kombinieren. Die Studiengruppen leisten sowohl in der Diagnostik – zum Beispiel durch die Etablierung zentraler Referenzlaboratorien – als auch in der Therapie einen essenziellen Beitrag zur Qualitätssicherung. Die regulatorischen Anforderungen an die Durchführung von TOS sind nach Inkrafttreten der 12. AMG-Novelle gewachsen. Für sie gelten nunmehr die gleichen Anforderungen wie für Zulassungsstudien der Industrie. Unter diesen Bedingungen konnten aufgrund des erheblichen bürokratischen Aufwands und der hohen Kosten nur noch wenige, vollständig industrieunabhängige große Multicenterstudien initiiert werden, das heißt, es zeichnet sich ein erheblicher Nachteil für die unabhängige akademische Forschung ab.

Abstract

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.

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Danksagung

Stellvertretend für die Multicenterstudiengruppen geht unser Dank an die zentralen Förderer der Therapieoptimierungsstudien, unter anderem BMBF, die Deutsche Krebshilfe und die Deutsche Jose Carreras Stiftung, die teilnehmenden Ärztinnen und Ärzte, das Studienpersonal der Kliniken und die Patienten.

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  1. Klinikum der Goethe Universität, Zentrum der Inneren Medizin, Medizinische Klinik II, Theodor Stern Kai 7, 60590, Frankfurt, Deutschland

    N. Gökbuget

  2. Onkologikum, Frankfurt, Deutschland

    D. Hoelzer

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  1. N. Gökbuget
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  2. D. Hoelzer
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Correspondence to N. Gökbuget.

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Gökbuget, N., Hoelzer, D. Bedeutung von Multicenterstudiengruppen für die klinische Forschung in der Hämatologie und Onkologie. Bundesgesundheitsbl. 52, 417–424 (2009). https://doi.org/10.1007/s00103-009-0830-8

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  • DOI: https://doi.org/10.1007/s00103-009-0830-8

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