临床研究与生物伦理学杂志

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Practical Application of International Standards and Guidelines to Address Ethical Challenges in Clinical Trials

Juntra Karbwang and Kesara Na-Bangchang

The aim of this article is to articulate how the international standards in clinical trials can assist in addressing ethical challenges when designing, conducting, analyzing, and reporting clinical trial. The ethical issues related to technical aspects of protocol are commonly seen in study design, selection of subjects, selection of control group, and estimation of sample size. The appropriate study design should be chosen to provide the desired information. Validity of research results depends on the extent to which investigators have been able to avoid all possible sources of bias. The techniques used to minimize biases are randomization, blinding, and the use of control group. Ethics committee members are required to evaluate whether the chosen study design is appropriate for the type of study under the circumstances and whether biases have been sufficiently managed.