COURSE UNIT TITLE

: CLINICAL TRIALS I

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
KIA 5005 CLINICAL TRIALS I COMPULSORY 2 2 0 12

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR MUKADDES GÜMÜŞTEKIN

Offered to

CLINICAL DRUG RESEARCH
TRANSLATIONAL MEDICINE

Course Objective

To evaluate practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines

Learning Outcomes of the Course Unit

1   to know and to be able to implement the national and international regulations in conducting clinical trials
2   to know and to be able to implement clinical trial design
3   to know and to be able to implement the fundamental biostatistical concepts in clinical trials
4   to be able to write clinical trial protocol synopsis
5   to know the responsibilities of clinical trial s parties

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 General concepts of Clinical Trials
2 Planning clnical trials (control group selection, randomisation, placebo use, inclusion/exclusion criterias)
3 Planning in clinical trials/incorrect planning results (control group selection, randomisation, placebo use, inclusion/exclusion criterias)
4 Planning and design in clinical trials I (Experimental studies, parallel design trials, cross pass trials, factorial trial design, consecutive design trials )
5 Planning and design in clinical trials II (observational studies: cohort studies, case-control studies, cross-sectional studies)
6 The aim of the clinical trials, hypotesis, measurement scales, endpoints, surragate endpoints
7 Fundemental biostatistical concepts in clinical trials I
8 Descriptive statistic
9 Parametric, nonparametric analysis selection
10 Parametric, nonparametric analysis selection
11 Estimating sample size in clinical trials
12 Survival analysis
13 Preperation of Clinical Trial protocol summary
14 Preperation of Clinical Trial protocol summary

Recomended or Required Reading

Textbook(s)/References/Materials:
Clinical Trials Handbook : Design and Conduct. Meinert, Curtis L. 2012. http://site.ebrary.com/lib/deulibrary/detail.action docID=10608725
Fundamentals of Clinical Trial. Friedman LM, Furberg CD, DeMets DL. 2010. http://link.springer.com/book/10.1007%2F978-1-4419-1586-3

Yerli kaynaklar :
Klinik Farmakolojinin Esasları ve Temel Düzenlemeler Prof Dr S O Kayaalp 5. Baskı, 2012
Klinik Araştırmalar Kitabı-2014 Editörler: Prof Dr H Akan, Dr H Ilbars, N Ömeroğlu Çetinkaya. Bilimsel Tıp Yayınevi, Ankara, 2014.

Planned Learning Activities and Teaching Methods

All the strategies are located Assesment methods and Total work load

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 PRF PERFORMANCE
2 FIN FINAL EXAM
3 FCG FINAL COURSE GRADE PRF * 0.40 + FIN*0.60
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) PRF * 0.40 + FCGR*0.60


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

Further Notes About Assessment Methods

None

Assessment Criteria

To be succesful in final exam and, to present a topic in course outline as a homework

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

gumustekinm@gmail.com, Tel: 4123906

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 2 28
Practice (Reflection) 14 2 28
Preparations before/after weekly lectures 14 9 126
Preparation for final exam 1 40 40
Preparing assignments 14 6 84
Final 1 2 2
TOTAL WORKLOAD (hours) 308

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10
LO.15542542343
LO.25553343333
LO.35345333232
LO.45555532523
LO.55542532523