Clinical research methods (CLRES 2010)

CLRES 2010 covers fundamental concepts and basic analytic methods pertaining to the design, analysis, and interpretation of clinical research studies. The course is broadly divided into three major analytic areas: (1) basic epidemiology and observational methods, (2) interventional and randomized controlled trials, and (3) clinical epidemiology and evidence-based medicine. Each section of the course will last 7–9 sessions and culminate in a short examination. The first section of the course will cover concepts of association and outcome, introduce standard epidemiologic concepts of incidence and prevalence, and define and describe relative risk, absolute risk, attributable risk, and the various methods for calculating these quantities in different observational research designs. Definitions of and methods for reducing bias and confounding are major components of this section. The second section introduces interventional trials, including the four phases of drug trials, the importance and effects of randomization, and the analysis and interpretation of controlled trials. Methods for comparing results across trials, as well as an introduction to nonstandard trial designs, are provided. The final section of the course introduces the concepts of clinical epidemiology, including evidence-based medicine, the interpretation of diagnostic tests, the construction and use of clinical prediction rules, and the evaluation of screening for chronic disease.


Identify important outcome measures for incorporation into patient oriented clinical trial design.

Design appropriate, ethically sound, and hypothesis-driven clinical studies.

Design appropriate experiments to address generated research questions in the pharmaceutical sciences.

Evaluate possible problems in the design and execution of a study in the pharmaceutical sciences.

Define bias in clinical and translational research.

Select the appropriate statistical approach for the interpretation of preclinical and clinical datasets.

Demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting the rights, well-being, and dignity in the recruitment and retainment of human subjects in clinical research.

Give examples of the informed consent process including an understanding of the risk/benefit criteria and its impact on the patient/volunteer.

* Highlight denotes properties specific to the Clinical Pharmaceutical Sciences track.