Korean J Biol Psychiatry.  2012 Nov;19(4):172-178.

Designing Clinical Studies and Keeping Research Ethics

• Chang JS
• Lee S
• Ha TH
• Yoon IY
• Ha K

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.

Keyword

Clinical study; Clinical trial; Observational study; Research ethics

MeSH Terms

Ethics, Research
Human Rights
Psychiatry