Final_Summary

Final_Summary - PM510: Intro to Biostatistics Design and...

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PM510: Intro to Biostatistics Design and Analysis of Clinical Studies Stanley Azen, Ph.D. Department of Preventive Medicine University of Southern California
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I. DESIGNING CLINICAL RESEARCH STUDIES
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A. Stating Objectives:Framing the Research Question, and B. Defining the Study Population
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Example 1: The Monitored Atherosclerosis Regression Study (MARS) Objective: To assess the effects of lipid-lowering therapy with lovastatin on coronary angiographic findings in persons with coronary artery disease Population: Subjects with angiographically defined coronary artery disease, under 70 years of age, both genders, cholesterol < 295 mg/dl
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Example 2: Ethnicity and Attitudes toward Patient Autonomy Objective: To study differences in the attitudes of elderly subjects from different ethnic groups toward disclosure of the diagnosis/prognosis of a terminal illness and toward end-of-life decision making Population: Subjects aged 65 years and older self- identified as being from one of four ethnic groups.
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Example 3: Long-Term Follow-up in the Cholesterol Lowering Atherosclerosis Study (CLAS) Objective: To determine whether progression of coronary artery disease, assessed by sequential coronary angiography, is positively related to the risk of subsequent coronary events Population: Non-smoking males, aged 40-59 yr, with coronary artery disease who had completed two coronary angiograms, two years apart as part of CLAS
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Example 4: Dietary and Other Lifestyle Factors in LA County Women with Brain Gliomas Objective: To determine whether diet and other exposures involving n-nitroso compounds and their precursors are related to the incidence of brain gliomas in females Population: Females, aged 25-74, diagnosed with intracranial gliomas in 1986-8, identified by the LA County population-based Cancer Surveillance program; and control females, not diagnosed with glioma, individually matched to each case on age, race, neighborhood of residence
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C. Selecting the Appropriate Design
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Examples (continued) MARS: Clinical Intervention Study -- multicentered, controlled, randomized clinical trial comparing two interventions (lovastatin vs. placebo) Ethnicity: Observational, Cross-sectional Study of four ethnic groups: European-Americans, African-Americans, Korean-Americans, Mexican- Americans
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Examples (continued) CLAS Follow-up: Observational, Cohort Study evaluating time to development of clinical events in patients treated in CLAS who had baseline and 2-year angiograms Glioma Study: Observational, Case-control Study evaluating risk factors associated with intracranial gliomas
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D. Defining the Study Variables
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Final_Summary - PM510: Intro to Biostatistics Design and...

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