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Research How-To’s in a Community Setting. Gregory W. Heath, DHSc, MPH Director of Research. Definitions . Clinical Research covers all studies of diseases and trials of treatments that take place in human subjects
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Research How-To’s in a Community Setting Gregory W. Heath, DHSc, MPH Director of Research
Definitions • Clinical Research covers all studies of diseases and trials of treatments that take place in human subjects • Translational Research describes the steps between a fundamental discovery and its application in clinical medicine.
Shifting Priorities in Academic Health Centers • Explosion in clinical service demands and reduction in financial margins, side-lines the training of clinician scientists • Marked increase in numbers of faculty leads to a “dilution”effect with a decreasing valuation attached to translational and clinical sciences • The complexity of knowledge needed to be an effective clinical or translational scientist is not easily acquired • Young clinical faculty have trouble finding time to pursue scholarly aspirations
Community-based Clinical Research • Collaboration – an enterprise between faculty, residents, and community partners • Communication – from the initial stages of a specific research question through the publication of generalizable information • Cooperation - within and between departments, institutions, agencies, and the general public • Coordination – among and between clinical investigators, their partners, and the greater community
There is no amount of grantsmanship that will turn a bad idea into a good one……..But there are many ways to disguise a good one. Dr. William Raub Past Deputy Director, NIH
Choosing Your Research Project • What Makes a Research Project Outstanding? • Has the potential to lead to seminal observations • Leads to new ways of thinking • Lays the foundation for further research in the field • Clearly defines the importance of the research problem • Has only two to three interrelated specific aims • Addresses a difficult problem in a way that seems simple in retrospect, leaving the reviewers to wonder why they didn't think of the idea first • Is written at a level understandable by all reviewers
Research Process • Define the question and specify the objectives • Review the relevant literature
Research Process • Establish the methodology What is the sample population? Existing data? What are the data collection instruments? What are the problems and how should they be address? Any gold standard instruments?
Research Process • Statistical Considerations Sample size and power Univariate approaches Stratification Multivariate analysis and modeling • Pilot Studies Work out problems Assess feasibility
Research Process • Conduct Develop protocol IRB Review Compliance issues
Outcomes of Community-based Clinical Research • Clear, effective, and coordinated rules for clinical research • Maximally effective human subjects protections • More comprehensive analysis and sharing of research data • Enhanced quality and productivity of the research enterprise