Implementation of prospective clinical research
About Course
This course focuses on the practical implementation of prospective clinical research, from study design and initiation to data analysis, publication, and translation into clinical practice. Through expert-led video lectures, you will learn the key methodological principles required to conduct high-quality clinical studies and gain practical guidance on the challenges encountered throughout the research process.
The course examines how to define an appropriate study population, establish inclusion and exclusion criteria, and determine sample size requirements. It also addresses the practical aspects of conducting clinical research, including ethical and regulatory considerations, study registration, site selection, and site initiation. In addition, the course explores the selection and evaluation of primary and secondary endpoints, data quality management, post hoc analyses, and the interpretation and dissemination of study findings through scientific publications and clinical practice guidelines.
Emphasis is placed on methodological rigor, critical appraisal, and the real-world application of research findings to improve patient care and advance hepatology research.
In this course, you will:
- Understand how to define study populations and establish appropriate inclusion and exclusion criteria.
- Learn the principles and practical considerations of sample size calculation.
- Explore the ethical, legal, and regulatory requirements for conducting prospective clinical research.
- Gain practical insight into study registration, site selection, and site initiation processes.
- Learn how to select, define, and evaluate primary and secondary clinical endpoints.
- Understand the role of data quality control, including data queries and management of study databases.
- Explore the principles, opportunities, and limitations of post-hoc analyses
- Learn how to prepare and publish scientific manuscripts arising from clinical research.
- Develop the skills to evaluate clinical studies critically and interpret their findings.
- Understand how clinical practice guidelines are developed and how research evidence informs recommendations.
- Strengthen your ability to translate clinical research findings into evidence-based practice.
Course Content
Population, inclusion and exclusion criteria
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01:53
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Video: Defining your target population
11:31 -
Video: Crafting robust inclusion and exclusion criteria
06:26 -
Video: Balancing generalizability, feasibility, and ethical imperatives
10:33 -
Video: Practical challenges and best practices
10:50 -
Video: Module 1 wrap-up
04:48 -
Readings
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Assignment S2C2M1-A01: Interactive quiz
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Assignment S2C2M1-A02: Interactive quiz
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Assignment S2C2M1-A03: Discussion
04:27
Sample size calculation
Practical issues and considerations
Evaluation of primary and secondary endpoints
Publishing a paper
Evaluation of clinical studies
Introduction to clinical practice guidelines
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