task force on design and analysis introduction to clinical research course outline bruce pihlstrom...
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Task Force on Design and Analysis
Introduction to Clinical Research
Course Outline
Bruce [email protected]
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
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
• 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
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
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
• 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
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
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)