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

2. 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. Goals

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. Course Introduction Definition of Clinical Research Types of Clinical research Cross-sectional Retrospective Prospective Observational: Case Control, Cohort Studies Interventional: Clinical Trials Good Clinical Practice Regulations / Guidelines Ethical Issues in Clinical Research Tuskegee Study; Belmont Report; Helsinki Declaration Informed Consent IRB’s/ Ethical Boards / DSMBs Vulnerable Populations (Children, Mentally challenged) Day 1: 8:30 AM – 12:00 Noon

5. Day 1: 1:00 PM – 5:00 PM Prominent Design Issues in Clinical Research Defining the Research Question Hypothesis Testing Efficacy vs. Effectiveness Causation vs. Association Confounding and Effect Modification Selection Bias Participation Bias Randomization Masking / Blinding (Single, double, triple) Use of Biomarkers and Surrogate measures Measurement error Primary and secondary outcome measures Clinical Significance / Meaning

6. Day 2: 9:00 AM – 12:00 Noon Prominent Statistical Issues /Concepts in Clinical Research Statistical Significance Statistical Power Data Analysis Sampling Independence Parametric vs. Non-Parametric Analysis Correlated or Clustered data (sites vs. subjects) Repeated Measures Analyses Post-hoc Multiple Comparisons Missing Data – Intention to Treat Analysis

7. Regulatory Issues in Oral Health Drug / Devices / Biologics OTC Drug Regulations Prescription Regulations Day 2: 1:00 PM – 4:30 PM Operational Issues in Clinical Research Research Personnel Roles and Responsibilities Certification Procedures Examiner Training /Calibration Subject Recruitment / Retention Data Management Role of Data Coordinating Centers

8. Day 3: 9:00 – 11:00 AM Publication of Results Abstracts and Manuscripts Authorship Writing and Submission NIH /NIDCR Support Grant Mechanisms – Grants / Contracts/ Co-op Agreements Solicitations: RFAs, PA, PARs, PAS Accessing NIH Opportunities and Program Staff Peer Review of NIH submitted Applications Funding Decisions NIH Oversight

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