CRC 230 - Clinical Research Design

3 Credits, 3 Contact Hours
3 lecture periods 0 lab periods

Introduction to the scientific concepts related to the design and analysis of clinical trials. Includes key elements of a clinical trial protocol, from hypothesis, trial development, to trial feasibility and analysis. Also includes ethical and human subject protection considerations relative to research protocol and trial execution.

Recommendation: Completion of or concurrent enrollment in CRC 101. If any recommended course is taken, see a financial aid or Veteran’s Affairs advisor to determine funding eligibility as appropriate.

Course Learning Outcomes

Explain the basic and complex types of research methods and how they relate to clinical trial design.
Apply ethical principles of research to clinical trial protocols and data collection procedures.
Describe how statistics and informatics relate to trial objectives, data analysis, and interpretation.
Discuss the evaluation and interpretation of clinical trials results.
Explore elements to present research findings.

Performance Objectives:

Identify Study Question, Objectives, and Procedures
Select an Optimal Study Approach to answer the Study Question.
Design the trial and create a data collection plan.
Discuss elements of Data Analysis
Communicate research findings.

Outline:

Scientific Approach Applied to Development of Research Protocol
1. Overall process of clinical research development
2. General Principles of investigational product regulation
Development of appropriate research hypothesis specific to each phase of protocol development
1. Selecting a Research Question
2. Reviewing the Literature
3. Defining Study-Specific Aims
  1. Background information including a synopsis of the properties of the investigational product
  2. Study objectives and purpose
  3. Study goals and endpoints
  4. Selection of subject and precedent for subject withdrawal
Selecting a Study Approach
1. Overview of research designs
2. Case Studies
3. Cross-Sectional Studies
4. Case-Control Studies
5. Cohort Studies
6. Experimental Studies
7. Qualitative Studies
8. Correlational Studies
9. Synthesis Research
Designing the Study and Data Collection
1. Research Protocols
2. Ethical Considerations
3. Ethical Review and Approval
4. Population Sampling, Sample Size, and Power
5. Collecting Quantitative and Qualitative Data
6. Developing Questionnaires and Assessments
Analyzing Data
1. Data Management
2. Descriptive and Comparative Statistics
3. Regression Analysis
4. Qualitative Analysis
5. Additional Analysis Tools
Reporting the Findings
1. Posters and Presentations
2. Article Structure
3. Citing