Course Details

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Course Information
SemesterCourse Unit CodeCourse Unit TitleT+P+LCreditNumber of ECTS CreditsLast Updated Date
5MBG420INTRODUCTION TO CLINICAL TRIALS3+0+03510.05.2026

 
Course Details
Language of Instruction English
Level of Course Unit Bachelor's Degree
Department / Program MOLECULAR BIOLOGY AND GENETICS
Type of Program Formal Education
Type of Course Unit Elective
Course Delivery Method Face To Face
Objectives of the Course The aim of this course is to provide students with a basic understanding of the principles of clinical trials, study designs, ethical considerations, and basic data analysis methods. By the end of the course, students will be able to interpret and critically evaluate clinical research findings.Developing understanding of statistical concepts such as bias, randomization, sample size, and power in clinical research.
Providing students with the ability to critically interpret and evaluate clinical trial results in the context of molecular biology and genetics.
Course Content This course introduces students to the fundamental principles of clinical trials, with applications in molecular biology and genetics. Students will learn how trials are designed, including ethical considerations, randomization, and blinding to minimize bias. The course emphasizes the importance of sample size and statistical power, enabling students to understand how studies are planned to detect meaningful effects reliably. Additionally, students will gain basic skills in analyzing trial data, interpreting continuous and binary outcomes, and evaluating evidence from systematic reviews and meta-analyses. By the end of the module, students will be able to critically assess the design and results of clinical trials in biomedical research.
Course Methods and Techniques The course will be conducted through theoretical lectures and applied problem-solving activities. Problems will be solved both theoretically and using computer-based applications, followed by interpretation of the results.
Prerequisites and co-requisities None
Course Coordinator None
Name of Lecturers Asist Prof.Dr. Gonca Buyrukoglu gonca.buyrukoglu@agu.edu.tr
Assistants None
Work Placement(s) No

Recommended or Required Reading
Resources Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of clinical trials. springer.
Course Notes Lecture Notes
Documents Canvas
Assignments Canvas
Exams Canvas

Course Category
Mathematics and Basic Sciences %100

Planned Learning Activities and Teaching Methods
Activities are given in detail in the section of "Assessment Methods and Criteria" and "Workload Calculation"

Assessment Methods and Criteria
In-Term Studies Quantity Percentage
Quiz/Küçük Sınav 1 % 25
Proje/Çizim 1 % 25
Final examination 1 % 50
Total
3
% 100

 
ECTS Allocated Based on Student Workload
Activities Quantity Duration Total Work Load
Yazılı Sınav 1 6 6
Proje 1 6 6
Ders dışı çalışma 14 10 140
Final Sınavı 1 2 2
Total Work Load   Number of ECTS Credits 5 154

 
Course Learning Outcomes: Upon the successful completion of this course, students will be able to:
NoLearning Outcomes
1 Describe the main types, phases, and purposes of clinical trials.
2 Explain how randomization and blinding are used to minimize different types of bias in experiments
3 Interpret basic analyses of clinical trial data, including continuous and binary outcomes.
4 Explain the importance of power and sample size calculations in both planning and analyzing clinical trials.

 
Weekly Detailed Course Contents
WeekTopicsStudy MaterialsMaterials
1 Foundations: Design, Bias & Ethics
2 Basic Analyses for Continuous Measures
3 Analyses of Binary Outcome
4 Trial Planning: Sample Size and Power Calculation (Part I)
5 Trial Planning: Sample size and Power Calculation (Part II)
6 Methods of Treatment Allocation in Randomised Controlled Trials
7 Statistical Analysis Including Baseline Data
8 The Analysis of Equivalence and Non-Inferiority Trials (Part I)
9 Analysis with Treatment Protocol Deviations
10 Crossover Trials (Part I)
11 Crossover Trials (Part II)
12 Systematic Reviews and Meta-analysis (Part I)
13 Systematic Reviews and Meta-analysis (Part II)
14 Course Review and Emerging Topics

 
Sustainable Development Goals
Contribution of Learning Outcomes to Programme Outcomes
P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
C1 5 5 3 4 3 3 4 2 2 2
C2 2 4 2 3 2 4 1 5 4 4
C3 4 5 3 4 3 4 4 1 2 1
C4 4 4 3 5 1 5 5 4 5 4

  Contribution: 1: Very Slight 2:Slight 3:Moderate 4:Significant 5:Very Significant

  
  https://sis.agu.edu.tr/oibs/bologna/progCourseDetails.aspx?curCourse=79439&lang=en
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