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| Unit | INSTITUTE OF MEDICAL SCIENCES |
| BIOSTATISTICS (MEDICINE) (PhD) | |
| Code | BİS601 |
| Name | Design and Analysis of Clinical Trials |
| Term | 2025-2026 Academic Year |
| Term | Fall and Spring |
| Duration (T+A) | 2-2 (T-A) (17 Week) |
| ECTS | 7 ECTS |
| National Credit | 3 National Credit |
| Teaching Language | Türkçe |
| Level | Doktora Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | |
| Course Instructor |
The current term course schedule has not been prepared yet.
|
Course Goal / Objective
The aim is to enable students to evaluate the clinical trial process from design to reporting with a statistical perspective.
Course Content
This course includes clinical trial designs, randomization techniques, blinding methods, and data analysis approaches.
Course Precondition
None
Resources
Friedman, L. M., Furberg, C., & DeMets, D. L. (2010). Fundamentals of Clinical Trials.
Notes
Piantadosi, S. (2017). Clinical Trials: A Methodologic Perspective.
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Describes the fundamental processes of clinical research. |
| LO02 | Compares and contrasts different clinical trial designs. |
| LO03 | Interprets clinical data analyses using appropriate statistical approaches. |
| LO04 | Plans ethical clinical studies in line with regulatory and scientific standards. |
| LO05 | Applies statistical software tools commonly used in clinical trial analysis. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Comprehends the original definitions, concepts and theorems that will bring innovation to the field based on the qualifications gained in the biostatistics master's program. | 2 |
| PLO02 | Bilgi - Kuramsal, Olgusal | Using knowledge that requires expertise, analyzes, evaluates and interprets new and complex ideas in the field and related fields. | |
| PLO03 | Bilgi - Kuramsal, Olgusal | He/She has advanced knowledge about technological tools and software that are frequently used in the field of biostatistics. | |
| PLO04 | Bilgi - Kuramsal, Olgusal | Knows the importance of ethical principles and ethical committees for the individual and society. Comprehends the importance of Biostatistician in ethics committees. | |
| PLO05 | Bilgi - Kuramsal, Olgusal | He/She has advanced knowledge about statistical methods that are frequently used in studies in the field of health. | |
| PLO06 | Beceriler - Bilişsel, Uygulamalı | Evaluates the knowledge in the field of biostatistics with a systematic approach | |
| PLO07 | Beceriler - Bilişsel, Uygulamalı | Develops a new idea, method, design or application that brings innovation to the field of biostatistics, develops a known idea, method, design or application and applies it to a different field. | |
| PLO08 | Beceriler - Bilişsel, Uygulamalı | Design, analyzes critically, interprets and reports observational and clinical researchs for new and complex problems in medicine and health sciences. | 5 |
| PLO09 | Beceriler - Bilişsel, Uygulamalı | He/She uses advanced statistical methods in the decision-making process in diagnosis and treatment in health sciences, and consults to researchers working in this field. | 5 |
| PLO10 | Beceriler - Bilişsel, Uygulamalı | Uses research and analysis methods that require high-level skills in studies related to the field of biostatistics. | |
| PLO11 | Beceriler - Bilişsel, Uygulamalı | Develops and applies advanced statistical methods and techniques frequently used in health sciences at the level of expertise with original thought, research. | |
| PLO12 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Performs independently an original work that brings innovation to the field of biostatistics | |
| PLO13 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Performs advanced statistical analysis that can evaluate a scientific article. | |
| PLO14 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Develops the ability to read and write articles related to the field of biostatistics and apply for articles to national and/or international refereed journals. | |
| PLO15 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Takes an active role in solving original and interdisciplinary problems | |
| PLO16 | Yetkinlikler - Öğrenme Yetkinliği | Develops new ideas and methods in the field of Biostatistics by using high-level mental processes such as creative and critical thinking, problem solving and decision making. | |
| PLO17 | Yetkinlikler - Öğrenme Yetkinliği | Comprehends the ways to reach the evidence and evaluates the evidence critically. | 3 |
| PLO18 | Yetkinlikler - Öğrenme Yetkinliği | He/She determines the principles of lifelong learning and professional development as an attitude and displays this attitude in his/her works. | |
| PLO19 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Understands the dynamics of social relations required by the health profession and critically evaluates and develops the norms that guide these relations. | |
| PLO20 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Discusses the issues in the field with other experts in interdisciplinary studies, using effective communication skills, and provides academic consultancy by defending his/her original views. | 2 |
| PLO21 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Communicates written, verbal and visual with foreign language knowledge in international scientific environments | |
| PLO22 | Yetkinlikler - Alana Özgü Yetkinlik | By using the knowledge of biostatistics and medical informatics, he/she contributes to the society's becoming an information society by presenting his/her knowledge and skills to his/her society. | |
| PLO23 | Yetkinlikler - Alana Özgü Yetkinlik | Establishes functional interaction by defending original views in solving problems related to biostatistics | |
| PLO24 | Yetkinlikler - Alana Özgü Yetkinlik | Consults using effective communication skills, takes part in teamwork in research, defends scientific ethical rules | |
| PLO25 | Yetkinlikler - Alana Özgü Yetkinlik | He/She has the experience of working with other health disciplines as a requirement of the field. | 2 |
| PLO26 | Yetkinlikler - Alana Özgü Yetkinlik | He/she chooses and applies the correct statistical methods in his/her studies in the field of health and interprets them correctly. Performs advanced analysis and synthesis. | 4 |
| PLO27 | Yetkinlikler - Alana Özgü Yetkinlik | Uses current developments and information in the field of health for the benefit of society in line with the realities of the country. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Introduction and course overview | Reading | Öğretim Yöntemleri: Bireysel Çalışma, Tartışma |
| 2 | Introduction to clinical trials | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 3 | Types of clinical trials | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 4 | Randomization methods | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 5 | Blinding and bias | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 6 | Sample size calculations | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 7 | Data collection methods | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 8 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav |
|
| 9 | Ethical principles in clinical trials | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 10 | Monitoring and reporting | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 11 | Data analysis and interpretation | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 12 | Reporting of results | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 13 | Meta-analysis and systematic review | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 14 | Software applications in clinical trials | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 15 | General evaluation and review | Reading | Öğretim Yöntemleri: Bireysel Çalışma |
| 16 | Term Exams | Ölçme Yöntemleri: Ödev, Yazılı Sınav |
|
| 17 | Term Exams | Ölçme Yöntemleri: Performans Değerlendirmesi |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 4 | 56 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 4 | 56 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 1 | 20 | 20 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 20 | 20 |
| Final Exam | 1 | 20 | 20 |
| Total Workload (Hour) | 172 | ||
| Total Workload / 25 (h) | 6,88 | ||
| ECTS | 7 ECTS | ||