생물정신의학 (Korean Journal of Biological Psychiatry)

  • 제19권4호
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  • Pages.153-158
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  • 2012
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  • 1225-8709(pISSN)
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  • 2005-7571(eISSN)
대한생물정신의학회 (The Korean Society of Biological Psychiatry)
권호 표지

임상시험의 단계별 이해 및 실제

Understanding of Clinical Trials and Application to the Real Practice

  • 최성구 (한국얀센 NeuroScience 사업부)
  • 투고 : 2012.07.09
  • 심사 : 2012.08.13
  • 발행 : 2012.11.30
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초록

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

키워드

참고문헌

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