Course Description
The conceptual framework for design and implementation of intervention studies. A detailed understanding of experimental design options; methods of randomization; blinding; developing interventions and controls; measuring outcomes and adverse effects; follow-up; compliance and ethical issues pertinent to clinical trials will be emphasized.
Athena Title
CLINICAL STUDIES
Prerequisite
EPID 7020 and BIOS 7020
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Course Objectives
At the end of this course, students should have facility with the principles of intervention study design, comprehend ethical principles pertaining to intervention studies, be proficient in evaluation of methodologic rigor and practical issues relevant for clinical trials implementation, and confidently communicate results from Clinical Trials to scholarly and lay audiences. Student Learning Outcomes: 1. Recognize and articulate the fundamental concepts used in the design of Phase I-III clinical trials, including endpoint determination, randomization, blinding, power, and interim stopping rules. 2. Design focused intervention research questions. 3. Specify the inclusion/exclusion criteria for intervention studies. 4. Describe the process/mechanics of randomization, blinding, blocking. 5. Articulate the importance of randomization, blinding, blocking for intervention studies. 6. Assess the adequacy of randomization in published intervention studies. 7. Describe the general approach to analysis of intervention studies and make appropriate inferences based on intervention studies.
Topical Outline
• Introduction to Clinical Trials • Specifying the Primary Trial Question • Definition of Study Population • Survey of Trial Study Design options • Key concepts in clinical trial design and implementation o Randomization o Blinding o Sample Size Determination • Recruitment and Follow-up of Study Participants • Data Collection, Quality Assurance and Quality Control • Monitoring and Reporting of Adverse Events • Monitoring Participant Adherence • Key principles of Clinical Trial Analysis, Reporting and Result Interpretation • Practical Aspects of a Clinical Trial (General) o Ethical Consideration and IRB Issues o Data Safety Monitoring Board o Creating, Piloting and Refining Data Collection Instruments o Effecting Randomization • Practical Aspects of a Clinical Trial 2 (Emphasis on Resource Limited Settings) o Ethical Considerations o Space limitations o Cultural adaptation, Translation and Piloting of instruments o Identifying and/or training appropriate local Collaborators, Co-investigators, and Staff o Sub-Contracts, etc.
Syllabus
Public CV