# COURSE UNIT TITLE

: STATISTICAL PLANNING IN CLINICAL TRIALS

#### Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
MIF 5015 STATISTICAL PLANNING IN CLINICAL TRIALS ELECTIVE 2 0 0 5

#### Offered By

Medical Informatics

#### Level of Course Unit

Second Cycle Programmes (Master's Degree)

#### Course Coordinator

PROFESSOR DOCTOR SELMA GÜRLER

#### Offered to

Medical Informatics
CLINICAL DRUG RESEARCH

#### Course Objective

The objective of the course is to gain information and experience regarding basic principles and appropriate study designs in planning clinical studies.

#### Learning Outcomes of the Course Unit

 1 The student should define basic concepts of the statistics, 2 Define basic concepts for design of experiment, 3 Plan appropriate design of experiment in clinical studies, 4 Plan a experimental design, 5 Interpret obtained experiment results

Face -to- Face

None

None

#### Course Contents

 Week Subject Description 1 Principles of the experiment planning 2 Basic statistical concepts 3 Basic statistical concepts 4 Basic statistical concepts 5 Simple comparison experiments 6 Simple comparison experiments 7 Midterm exam 8 One factor experiments and analysis of variance 9 Random completed block design 10 Random completed block design 11 Cross and repetitive measures 12 Cross and repetitive measures 13 Cross and repetitive measures 14 Multi-factor experiments 15 Final Exam

Textbook(s):
1. Montgomery, D.C. 1991, Design and Analysis of Experiments, John Wiley and Sons.
Supplementary Book(s):
1. Şenoğlu B., Acıtaş Ş. 2010, Istatistiksel Deney Tasarımı: Sabit etkili modeller, Nobel Yayın Dağıtım. Tic. Ltd. Şti.
References:
Materials:

#### Planned Learning Activities and Teaching Methods

Problem analysis, design and application, presentation/lecturing and interactive discussion.

#### Assessment Methods

 SORTING NUMBER SHORT CODE LONG CODE FORMULA 1 MTE MIDTERM EXAM 2 ASG ASSIGNMENT 3 FIN FINAL EXAM 4 FCG FINAL COURSE GRADE MTE* 0.25 + ASG* 0.25 + FIN* 0.50 5 RST RESIT 6 FCGR FINAL COURSE GRADE (RESIT) MTE* 0.25 + ASG* 0.25 + RST* 0.50

*** Resit Exam is Not Administered in Institutions Where Resit is not Applicable.

None

#### Assessment Criteria

Evaluation of homeworks, projects and exams.

Turkish

#### Course Policies and Rules

Attendance is an essential requirement of this course and is the responsibility of the student. Students are expected to attend all lecture and recitation hours. Attendance must be at least 70% for the lectures.

#### Contact Details for the Lecturer(s)

Dokuz Eylül University, Faculty of Science, Department of Statistics
e-mail: selma.gurler@deu.edu.tr
Tel: 0232 301 85 71

To be announced.

#### Work Placement(s)

None

 Activities Number Time (hours) Total Work Load (hours) Lectures 13 2 26 Preparations before/after weekly lectures 15 2 30 Preparation for midterm exam 1 15 15 Preparation for final exam 1 15 15 Preparing assignments 1 22 22 Preparing presentations 1 15 15 Final 1 2 2 Midterm 1 2 2 TOTAL WORKLOAD (hours) 127

#### Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10
LO.12225222222
LO.22223222222
LO.33233222222
LO.42222322222
LO.52222222222