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 Dr. William Raub Past Deputy Director, NIH Past Deputy Director, NIH

The Spark of Inquiry

Choosing Your Research Project What Makes a Research Project Outstanding?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 objectivesDefine the question and specify the objectives Review the relevant literatureReview the relevant literature

Research Process Establish the methodologyEstablish 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 ConsiderationsStatistical Considerations Sample size and power Univariate approaches Stratification Multivariate analysis and modeling Pilot StudiesPilot Studies Work out problems Assess feasibility

Research Process ConductConduct Develop protocol IRB Review Compliance issues

In God We Trust…. All Others Must Bring Data.

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