Clinical Trial Design and Literature Evaluation

This course is a practical application of biostatistics in the context of designing clinical or research protocols and reading research literature. During the first half of the course, students will learn to differentiate among study designs commonly used in medical, biomedical and healthcare research. Based on their knowledge of biostatistics, student will design a research protocol, selecting the appropriate study design, outcome measures and statistical package. During the second half of the course, students will build upon their knowledge of biostatistics and study design to read and critically evaluate current research selected from the literature. Topics include identifying the research question, the study design, bias and confounding, the study population, outcome measures, clinical research ethics and regulation, as well as identifying the testable hypothesis and evaluating the statistical analysis presented by the authors.

Biostatistics or approval from instructor.

Differentiate between study designs commonly used in medical, biomedical and healthcare research
Based on the study question, select an appropriate study design
Select the appropriate statistical test based on the study design and data type
Assess the internal validity of a research paper
Demonstrate proficiency in written and oral communication, and teamwork