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Task Force on Design and Analysis Introduction to Clinical Research Course Outline To Register, Contact Bruce Pihlstrom

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

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Task Force on Design and Analysis Introduction to Clinical Research Course Outline To Register, Contact Bruce Pihlstrom

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  1. Task Force on Design and AnalysisIntroduction to Clinical ResearchCourse OutlineTo Register, Contact Bruce Pihlstrom bpihls@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 • 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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