Study design in clinical research

Description:

Study Design in Clinical Research provides an in-depth overview of the various study designs employed in clinical research. The course focuses on understanding the strengths and weaknesses of each design, enabling researchers to make informed decisions when selecting an optimal design to answer their research questions. Participants will gain insights into both observational and experimental studies and learn how to differentiate between primary and secondary study designs.

Eligible Audience:

• Graduate students and early-career researchers in clinical or public health fields
• Professionals in the healthcare industry aiming to understand clinical research methodologies
• Aspiring clinical researchers and medical practitioners
• Academics involved in designing or reviewing clinical studies

Content:

Module 1: Introduction to Clinical Research Study Designs

• Definition and importance of study design in research
• Overview of observational and experimental studies
• Importance of study design selection in answering research questions

Module 2: Observational Studies

• Case-Control Studies
  • Characteristics, strengths, and limitations
  • Common applications in clinical research
• Cohort Studies
  • Distinguishing features and practical uses
  • Prospective vs retrospective cohort designs
• Cross-Sectional Studies
  • Snapshot analysis of data
  • Ideal use cases and limitations

Module 3: Experimental Studies

• Randomized Controlled Trials (RCTs)
  • Fundamental principles and design structure
  • Advantages in assessing causality
  • Challenges and ethical considerations

Module 4: Primary vs Secondary Study Designs

• Key differences between primary and secondary designs
• Examples and applications of each design
• Integration of study design in systematic reviews and meta-analyses

Module 5: Practical Application of Study Designs

• Case studies to identify optimal study design
• Group discussion: Choosing the right design for real-world scenarios

Course Outcomes:

By the end of this course, participants will:

1. Differentiate between observational and experimental study designs.
2. Identify key features, strengths, and limitations of various study designs, including case-control, cohort, cross-sectional, and RCTs.
3. Understand the differences between primary and secondary study designs and their applications.
4. Select the most appropriate study design for specific research objectives.

Instructor:

Dr. Nardin Zarif

• Head of clinical research department at Al-Anfoushi hospital in Alexandria,Egypt.
• MSC in pharmacogenomics and personalized medicine from faculty of pharmacy Alexandria university. 
• CSRT scholarship from Harvard University.
• her areas of interest include pharmacogenomics, epigenomics, transcriptomics, and bioinformatics.