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Urologic Oncology pp 1–40Cite as

Clinical Trials and Their Principles in Urologic Oncology

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Abstract

Clinical trials represent a relevant link between cancer research and clinical practice and provide the basis for evidence-based medicine. Trials in uro-oncology are essential for moving new methods of preventing, diagnosing, and treating cancer from the labs to clinical settings with the ultimate goal to improve care and quality of life of cancer patients.

Clinical trials impact the treatment of individual patients by selecting therapies; in addition, they affect also the societies’ health systems by evaluating and possibly enhancing the value of provided treatment options. Clinical trial conduction also harbors the potential of posing unknown risks to participants. Additionally, it needs to be considered that potentially biased knowledge retrieved from trials may harm patients. Hence, clinical trial implementation involves a rigorous approach based on scientific, statistical, ethical, and legal considerations.

In this chapter, commonly applied trial designs and relevant aspects of designing clinical studies will be contemplated. The aim is to provide sufficient background needed for proper interpretation of research findings and translating clinical trial results into clinical practice, which will support evidence-based clinical decision-making aiming at the best healthcare for each individual patient. Another objective is to provide basic guidance for the scientific community in the production of reliable evidence. Moreover, ethical principles related to clinical research including the topic of equipoise will be highlighted. Finally, the dilemmas and hurdles encountered in planning and executing trials will be touched. Ultimately one focus will be set on research in uro-oncology surgery which faces specific hurdles different to clinical trials for drug development.

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Authors and Affiliations

  1. Department of Urology, Ludwig-Maximilians University Munich, Grosshadern, Munich, Germany

    Sabine D. Brookman-May

  2. Janssen Pharma Research and Development, Los Angeles, CA, USA

    Sabine D. Brookman-May

  3. Department of Urology, Parc de Salut Mar- IMIM, Universitat Autónoma de Barcelona, Barcelona, Spain

    Maria Carmen Mir

  4. Department of Urology, Klinikum St. Elisabeth Straubing, Straubing, Germany

    Matthias May

  5. Department of Urology, Addenbrooke’s Hospital, Cambridge, UK

    Tobias Klatte

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  1. Sabine D. Brookman-May
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  2. Maria Carmen Mir
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  3. Matthias May
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  4. Tobias Klatte
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Correspondence to Sabine D. Brookman-May .

Editor information

Editors and Affiliations

  1. Dept. of Urology & Urologic Oncology, Hannover Medical School, Hannover, Germany

    Axel S. Merseburger

  2. Dept. of Urology, University of Regensburg St. Josef Medical Centre, Regensburg, Germany

    Maximilian Burger

Section Editor information

  1. Klinik und Poliklinik für Urologie, Universität Regensburg/Caritas-Krankenhaus St. Josef, Landshuter Str. 65, 93053, Regensburg, Germany

    Maximilian Burger

  2. Department of Urology, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538, Lübeck, Germany

    Axel S. Merseburger

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Brookman-May, S.D., Mir, M.C., May, M., Klatte, T. (2017). Clinical Trials and Their Principles in Urologic Oncology. In: Merseburger, A., Burger, M. (eds) Urologic Oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-42603-7_54-1

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  • DOI: https://doi.org/10.1007/978-3-319-42603-7_54-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-42603-7

  • Online ISBN: 978-3-319-42603-7

  • eBook Packages: Springer Reference MedicineReference Module Medicine

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