Designing Clinical Studies and Keeping Research Ethics

임상연구의 설계 및 연구윤리

  • Chang, Jae Seung (Department of Psychiatry, Seoul National University Bundang Hospital) ;
  • Lee, Sunny (Department of Psychiatry, Seoul National University Bundang Hospital) ;
  • Ha, Tae Hyon (Department of Psychiatry, Seoul National University Bundang Hospital) ;
  • Yoon, In-Young (Department of Psychiatry, Seoul National University Bundang Hospital) ;
  • Ha, Kyooseob (Department of Psychiatry, Seoul National University Bundang Hospital)
  • 장재승 (분당서울대학교병원 정신건강의학과) ;
  • 이선이 (분당서울대학교병원 정신건강의학과) ;
  • 하태현 (분당서울대학교병원 정신건강의학과) ;
  • 윤인영 (분당서울대학교병원 정신건강의학과) ;
  • 하규섭 (분당서울대학교병원 정신건강의학과)
  • Received : 2012.07.20
  • Accepted : 2012.09.24
  • Published : 2012.11.30

Abstract

Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

Keywords

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