Task Force on Design and Analysis

Introduction to Clinical Research

Course Outline

Bruce Pihlstrombpihls@umn.edu

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)