臨床研究の進め方  [in Japanese] How to Advance Clinical Research  [in Japanese]

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Author(s)

    • 関根 郁夫 Sekine Ikuo
    • 筑波大学医学医療系臨床腫瘍学 Department of Medical Oncology, Faculty of Medicine, University of Tsukuba
    • 鈴木 敏夫 Suzuki Toshio
    • 筑波大学医学医療系臨床腫瘍学 Department of Medical Oncology, Faculty of Medicine, University of Tsukuba
    • 山田 武史 Yamada Takeshi
    • 筑波大学医学医療系臨床研究地域イノベーション学|つくば臨床医学研究開発機構 Department of Clinical Research and Regional Innovation, Faculty of Medicine, University of Tsukuba|Tsukuba Clinical Research & Development Organization, University of Tsukuba
    • 鈴木 英雄 Suzuki Hideo
    • 筑波大学医学医療系臨床腫瘍学 Department of Medical Oncology, Faculty of Medicine, University of Tsukuba

Abstract

<p>研究とは「問い」に対する「答え」を徹底的に探し求めることであるが,現在では科学的発見の技術への応用も視野に入れて包括的に定義されている.臨床研究は患者を直接対象とする患者指向型研究と,患者から得た組織,細胞,血液などを用いる疾患指向型研究に大別される.研究は,「問い」の着想(新しいアイデア,リサーチ・クエスチョン),研究の計画(研究仮説,コンセプト・シート,プロトコール,倫理審査委員会の承認,研究データベースへの登録),研究の実施(プロトコール遵守,モニタリング,データマネージメント),結果の分析(仮説の検証),考察と結論(内的・外的妥当性の検討),発表というように段階的に進む.コンセプト・シートは幅広い研究者に送って研究デザインについての助言と協力を得る.研究実施体制を構築するこの段階が特に重要で難しいところである.近年,製薬企業によるグローバル治験が新規抗がん薬の開発を推し進めるようになり,臨床医が臨床試験における「問い」を出す余地は少なくなった.対照的に疾患指向型研究は著しい発展を見せており,臨床医には学際的に異なる領域の人たちを巻き込んで研究していく姿勢が期待されている.</p>

<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

    The Japan Lung Cancer Society

Codes

  • NII Article ID (NAID)
    130007896393
  • Text Lang
    JPN
  • ISSN
    0386-9628
  • Data Source
    J-STAGE 
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