How to Advance Clinical Research

DOI Web Site 4 References
  • Sekine Ikuo
    Department of Medical Oncology, Faculty of Medicine, University of Tsukuba
  • Suzuki Toshio
    Department of Medical Oncology, Faculty of Medicine, University of Tsukuba
  • Yamada Takeshi
    Department of Clinical Research and Regional Innovation, Faculty of Medicine, University of Tsukuba Tsukuba Clinical Research & Development Organization, University of Tsukuba
  • Suzuki Hideo
    Department of Medical Oncology, Faculty of Medicine, University of Tsukuba

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  • 臨床研究の進め方

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<p>At present, research is comprehensively defined as the exhaustive quest for "an answer" to "a question" and systemic investigation aimed at the application of a scientific discovery to technologies. Clinical research is classified into patient-oriented research, in which subjects are patients, and disease-oriented research, in which patient-derived tissue, cell and blood samples are investigated. The research proceeds in a step-by-step manner, with conceiving a question (an original idea and research question), planning (research hypothesis, concept sheet, protocol, approval by ethics committee, and registration to research database), implementing (protocol adherence, monitoring, and data management), analyzing the results (verification of the research hypothesis), discussing the findings and drawing a conclusion (evaluation of internal and external validity), and publishing the research. A concept sheet should be distributed to a wide range of researchers to receive advice on the study design and collaboration. This is a critical and difficult step for establishing an implementation system for research. As pharmaceutical industry-sponsored global clinical trials have accelerate anticancer drug development, there remains little room for clinical doctors to explore their original ideas in clinical trials. In contrast, disease-oriented research is progressing remarkably. Clinical doctors are expected to adopt an interdisciplinary approach in cooperation with experts of different fields.</p>

Journal

  • Haigan

    Haigan 60 (4), 292-297, 2020-08-20

    The Japan Lung Cancer Society

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