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Goals

Task Force on Design and Analysis Introduction to Clinical Research Course Outline Bruce Pihlstrom bpihls@umn.edu. Goals.

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Goals

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  1. Task Force on Design and AnalysisIntroduction to Clinical ResearchCourse OutlineBruce Pihlstrombpihls@umn.edu

  2. Goals 1. Provide junior faculty and new industry employees with a basic understanding of the fundamentals of clinical research.2. Encourage participation as investigators in clinical research and encourage further training in clinical research.

  3. Eligibility and Tuition: • Enrollees must have an appointment at a dental or medical school or be employed by industry • Enrollees will pay all travel and lodging expenses • Breakfast and lunch will be provided • Tuition: $150 per person

  4. Day 1: 8:30 AM – 12:00 Noon • Course IntroductionDefinition of Clinical ResearchTypes of Clinical research Cross-sectional RetrospectiveProspective • Observational: Case Control, Cohort StudiesInterventional: Clinical Trials • Good Clinical Practice Regulations / Guidelines • Ethical Issues in Clinical ResearchTuskegee Study; Belmont Report; Helsinki DeclarationInformed ConsentIRB’s/ Ethical Boards / DSMBsVulnerable Populations (Children, Mentally challenged)

  5. Day 1: 1:00 PM – 5:00 PM • Prominent Design Issues in Clinical Research • Defining the Research QuestionHypothesis TestingEfficacy vs. EffectivenessCausation vs. AssociationConfounding and Effect ModificationSelection BiasParticipation BiasRandomizationMasking / Blinding (Single, double, triple)Use of Biomarkers and Surrogate measuresMeasurement errorPrimary and secondary outcome measuresClinical Significance / Meaning

  6. Day 2: 9:00 AM – 12:00 Noon • Prominent Statistical Issues /Concepts in Clinical Research • Statistical SignificanceStatistical PowerData AnalysisSampling IndependenceParametric vs. Non-Parametric AnalysisCorrelated or Clustered data (sites vs. subjects)Repeated Measures Analyses Post-hoc Multiple ComparisonsMissing Data – Intention to Treat Analysis

  7. Day 2: 1:00 PM – 4:30 PM • Regulatory Issues in Oral Health Drug / Devices / BiologicsOTC Drug RegulationsPrescription Regulations • Operational Issues in Clinical ResearchResearch Personnel Roles and ResponsibilitiesCertification ProceduresExaminer Training /CalibrationSubject Recruitment / RetentionData ManagementRole of Data Coordinating Centers

  8. Day 3: 9:00 – 11:00 AM • Publication of Results   Abstracts and ManuscriptsAuthorshipWriting and Submission • NIH /NIDCR Support Grant Mechanisms – Grants / Contracts/ Co-op Agreements Solicitations: RFAs, PA, PARs, PASAccessing NIH Opportunities and Program StaffPeer Review of NIH submitted ApplicationsFunding DecisionsNIH Oversight

  9. Day 3: 11:00 AM – 12 Noon • Educational Opportunities for Further Training in Clinical Research Short-Term Training ProgramsNIH supported masters or doctoral level degree level programs • Clinical Translational Science Award (CTSAs)Institutional K-12 or K-30 type programsIndividual K awards (K-24 Programs)

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