Clinical Research Design and Biostatistical Methods

Song, Kijun; Han, Mooyoung; Cheong, My Young; Lim, Kil Seob; Kim, Dong Kee

Abstract

Purpose
To proceed effectively with clinical research requires an understanding of the fundamental principles of study design and biostatistical methods. In this article, we identified and summarized basic clinical research designs and some of the key biostatistical methods that have been commonly used in clinical research.
Materials and Methods
In an observational study, cross-sectional, case- control and Cohort designs were illustrated and compared. In a clinical trial study, parallel group design and cross-over designs were described according to their characteristics. Also, the biostatistical methods for their usages classified and summarized.
Results
Understanding and evaluating research design are part of the process researchers must use to determine both the quality and usefulness of their research. Adequate applications to biostatistical methods are need; i.e., descriptive statistics, Student's t-test, ANOVA, nonparametrics, categorical data analysis, correlation and regression, and survival analysis.
Conclusions
Research findings are used by clinical researcher to guide their practice and reduce their uncertainty in clinical decision making. However, to understand how to interpret research results, it is important to be able to understand basic statistical concepts and types of study design. Clinicians should also appropriately choose the biostatistical methods to suit their purposes.