Session+01+-+Design+and+Analysis+of+Clinical+Research+04-02-17

Session+01+-+Design+and+Analysis+of+Clinical+Research+04-02-17

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Design and Analysis of Clinical Research Sherrie H. Kaplan, PhD, MPH MS-BATS/Lecture 1 Spring Quarter 2016
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Course Overview Course content, objectives, readings Course requirements: readings, final paper (grant proposal draft) Class participation, presentations Selection of discussion papers
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Readings Readings drawn from: Designing Clinical Research 3 rd Edition Appropriate papers from the clinical literature to reflect research design topics Papers of interest may be identified by class participants Papers will be presented and discussions led by class participants
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Assignments, Presentations Written assignments: NIH/PCORI formatted biosketch Reviews of 3 grant proposals (to be discussed in class as group ‘mock study section’) Preparation of a draft grant proposal Class presentations: Minimum of two papers from literature as class discussant Final presentation of draft grant proposal
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“Anatomy” of Research: Elements of Research Studies Objectives/Specific aims: Identifying a ‘researchable’ question Background and significance: Putting the research question into context Preliminary studies - Recent evidence supporting feasibility, ‘fundability’ of proposed study
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“Anatomy” of Research: Elements of Research Studies Research Plan Study design, interventions, assignment strategy Subjects Selection/exclusion criteria Sampling strategy Recruitment Description of study measures Primary outcomes, independent variables/covariates
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“Anatomy” of Research: Elements of Research Studies Research Plan (cont’) Statistical Analysis Aim/hypothesis specific analytic plans Sample size, power Data Management Timeline Organizational capacity
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“Anatomy” of Research: Elements of Research Studies Human subjects, ethical issues Administrative parts Budget and budget justification Biosketches of key personnel Resources, equipment, physical facilities
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“Physiology” of Research: Scientific Workings of Research On the nature of drawing inference: Who is the target population? Is it well represented by the study sample? What is the phenomenon of interest? Is it well represented by study measures? On the nature of causality: Criteria for causality: temporality, plausibility, rule-out alternative competing hypotheses (se Hill ’s criteria for causality)
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Clinical Research Designs Case report Cross-sectional Case-control* Longitudinal cohort* Randomized controlled trial (RCT)* Hypothesis Generating *Hypothesis Testing
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Number of Active Trials by Country
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Number of Active Trials by State
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Why Experiment?
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  • Spring '08
  • Subramani
  • Clinical trial, external validity, internal validity

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