Approval procedures for clinical trials in the field of radiation oncology

被引:4
|
作者
Simon, Monique [1 ,2 ,3 ,4 ]
Habeck, Matthias [5 ]
Buettner, Daniel [1 ,2 ,3 ,4 ]
Habeck, Uta [5 ]
Noelling, Torsten [6 ]
Krause, Mechthild [1 ,2 ,3 ,4 ,7 ]
Brix, Gunnar [5 ]
Willich, Normann [8 ]
Wenz, Frederik [9 ]
Schmidberger, Heinz [10 ]
Debus, Juergen [1 ,11 ]
Baumann, Michael [1 ,2 ,3 ,4 ,7 ]
机构
[1] DKTK, Dresden, Germany
[2] Deutsch Krebsforschungszentrum DKFZ, Heidelberg, Germany
[3] Tech Univ Dresden, Fak Med, Natl Zentrum Strahlenforsch Onkol, Klin Strahlentherapie & Radioonkol & OncoRay, D-01307 Dresden, Germany
[4] Tech Univ Dresden, Univ Klinikum Carl Gustav Carus, D-01307 Dresden, Germany
[5] Fachbereich Strahlenschutz & Gesundheit, BfS, D-85764 Neuherberg, Germany
[6] Rechtsanwalt & Fachanwalt Med Recht Torsten Nolli, Leipzig, Germany
[7] Helmholtz Zentrum Dresden Rossendorf, Natl Zentrum Strahlenforsch Onkol, Inst Radioonkol & OncoRay, Dresden, Germany
[8] Univ Klinikum Munster, Klin Strahlentherapie Radioonkol, Munster, Germany
[9] Heidelberg Univ, Univ Med Mannheim, Med Fak Mannheim, Klin Strahlentherapie & Radioonkol, Mannheim, Germany
[10] Univ Med Mainz, Klin Radioonkol & Strahlentherapie, Mainz, Germany
[11] Univ Klinikum Heidelberg, Klin Radioonkol & Strahlentherapie, Heidelberg, Germany
关键词
Clinical research; Radiation treatments; Research and development; Approval; Regulations; BREAST-CANCER; RADIOTHERAPY; PROSTATE; THERAPY;
D O I
10.1007/s00066-015-0914-3
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background and purpose Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt fur Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. Methods A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Results Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. Conclusion An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unneccesary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.
引用
收藏
页码:909 / 920
页数:12
相关论文
共 50 条
  • [1] Genehmigungsverfahren klinischer Studien im Bereich der RadioonkologieApproval procedures for clinical trials in the field of radiation oncology
    Monique Simon
    Matthias Habeck
    Daniel Büttner
    Uta Habeck
    Torsten Nölling
    Mechthild Krause
    Gunnar Brix
    Normann Willich
    Frederik Wenz
    Heinz Schmidberger
    Jürgen Debus
    Michael Baumann
    Strahlentherapie und Onkologie, 2015, 191 : 909 - 920
  • [2] Radiation oncology clinical trials
    Hynds, S.
    CLINICAL ONCOLOGY, 2007, 19 (03) : S32 - S33
  • [3] Clinical radiation oncology trials in Germany
    Fietkau, Rainer
    Wenz, Frederik
    STRAHLENTHERAPIE UND ONKOLOGIE, 2015, 191 (12) : 907 - 908
  • [4] Clinical Trials and Radiation Oncology Technologies
    Michalski, Jeff M.
    Bosch, Walter R.
    Purdy, James A.
    ONCOLOGY-NEW YORK, 2009, 23 (04): : 386 - 389
  • [5] Optimizing accrual to radiation oncology clinical trials
    Corr, T
    van Tongeren, C
    Whitaker, K
    Baerg, B
    Keane, T
    RADIOTHERAPY AND ONCOLOGY, 2005, 76 : S50 - S51
  • [6] Clinical trials in Radiation Oncology: Methodologic approach
    Gourgou, S.
    Azria, D.
    CANCER RADIOTHERAPIE, 2022, 26 (6-7): : 803 - 807
  • [7] Quality improvements in radiation oncology clinical trials
    Smith, Koren
    Ulin, Kenneth
    Knopp, Michael
    Kry, Stephan
    Xiao, Ying
    Rosen, Mark
    Michalski, Jeff
    Iandoli, Matthew
    Laurie, Fran
    Quigley, Jean
    Reifler, Heather
    Santiago, Juan
    Briggs, Kathleen
    Kirby, Shawn
    Schmitter, Kate
    Prior, Fred
    Saltz, Joel
    Sharma, Ashish
    Bishop-Jodoin, Maryann
    Moni, Janaki
    Cicchetti, M. Giulia
    FitzGerald, Thomas J.
    FRONTIERS IN ONCOLOGY, 2023, 13
  • [8] European clinical trials in paediatric radiation oncology
    Boterberg, Tom
    Dunlea, Cathy
    Harrabi, Semi
    Janssens, Geert O.
    Laprie, Anne
    Whitfield, Gillian
    Gaze, Mark N.
    LANCET CHILD & ADOLESCENT HEALTH, 2021, 5 (12): : 843 - 845
  • [9] IMPACT OF RADIATION RESEARCH ON CLINICAL-TRIALS IN RADIATION ONCOLOGY
    RUBIN, P
    VANESS, JD
    CLINICAL RADIOLOGY, 1989, 40 (01) : 68 - 75
  • [10] State of clinical trials in the field of oncology in Turkey
    Nayir, Erdinc
    Ata, Alper
    Erdogdu, Suleyman
    Arican, Ali
    TURK ONKOLOJI DERGISI-TURKISH JOURNAL OF ONCOLOGY, 2014, 29 (04): : 181 - +