Research How-To’s in a Research How-To’s in a Community SettingCommunity Setting

Gregory W. Heath, DHSc, Gregory W. Heath, DHSc, MPHMPH

Director of ResearchDirector 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 Shifting Priorities in Academic Health Centers 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 Community-based Clinical Research 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 There is no amount of grantsmanship that will turn grantsmanship that will turn

a bad idea into a good a bad idea into a good one……..one……..

But there are many ways to But there are many ways to disguise a good one.disguise a good one.

Dr. William Raub Dr. William Raub

Past Deputy Director, NIHPast Deputy Director, NIH

The Spark of InquiryThe Spark of Inquiry

Choosing Your Research Choosing Your Research ProjectProject

• What Makes a Research Project Outstanding?What Makes a Research Project Outstanding?– Has the potential to lead to seminal observationsHas the potential to lead to seminal observations– Leads to new ways of thinking Leads to new ways of thinking – Lays the foundation for further research in the field Lays the foundation for further research in the field – Clearly defines the importance of the research Clearly defines the importance of the research

problem problem – Has only two to three interrelated specific aims Has only two to three interrelated specific aims – Addresses a difficult problem in a way that seems Addresses a difficult problem in a way that seems

simple in retrospect, leaving the reviewers to simple in retrospect, leaving the reviewers to wonder why they didn't think of the idea first wonder why they didn't think of the idea first

– Is written at a level understandable by all reviewers Is written at a level understandable by all reviewers

Research ProcessResearch Process

• Define the question and specify the Define the question and specify the objectivesobjectives

• Review the relevant literatureReview the relevant literature

Research ProcessResearch Process

• Establish the methodologyEstablish the methodologyWhat is the sample population?What is the sample population?Existing data?Existing data?What are the data collection What are the data collection

instruments?instruments?What are the problems and how What are the problems and how

should should they they be address?be address?Any gold standard instruments?Any gold standard instruments?

Research ProcessResearch Process

• Statistical ConsiderationsStatistical ConsiderationsSample size and powerSample size and powerUnivariate approachesUnivariate approachesStratificationStratificationMultivariate analysis and Multivariate analysis and

modelingmodeling

• Pilot StudiesPilot StudiesWork out problemsWork out problemsAssess feasibilityAssess feasibility

Research ProcessResearch Process

• ConductConduct

Develop protocolDevelop protocol

IRB ReviewIRB Review

Compliance issuesCompliance issues

In God We Trust….In God We Trust….

All Others Must All Others Must Bring Data.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