COURSE UNIT TITLE

: CLINICAL TRIALS II

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
KIA 5008 CLINICAL TRIALS II ELECTIVE 1 0 0 6

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR MUALLA AYLIN ARICI

Offered to

CLINICAL DRUG RESEARCH
TRANSLATIONAL MEDICINE

Course Objective

Planning and implementation of clinical trials in special populations and in special drugs; and related regulations

Learning Outcomes of the Course Unit

1   To know and to be able to implement the national and international regulations in clinical trials
2   To know the responsibilities of participants in clinical trials
3   To be able to plan and conduct clinical trials in special populations
4   To be able to define orphan drugs
5   To know the properties and indications of biosimilar drugs
6   To be able to define off label use of drugs; discuss related problems and propose solutions
7   To know orphan drug s development strategies
8   To be able to report the findings of clinical trials as medical articles.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Clinical trials in psychiatric patients
2 Clinical trials in children
3 Clinical trials in woman
4 Clinical trials in elderly
5 Clinical trials in other vulnerable subjects
6 Medical device Clinical trials
7 Stem cell research
8 Development of biosimilar drugs
9 Clinical studies of biosimilar drugs
10 Development of orphan drugs
11 Pharmacogenetics in clinical trials
12 Investigator-initiated clinical trials
13 Research in standards, contracts, budgeting
14 Clinical drug research in national legal regulations Insurance
15 Clinical research publication conversion process

Recomended or Required Reading

Yabancı kaynaklar :
1. Concise Guide to Clinical Trials. Hackshaw AK. 2009. (DEÜ Kütüphanesi) http://site.ebrary.com/lib/deulibrary/reader.action docID=10308186
2. Clinical Trials Handbook : Design and Conduct. Meinert, Curtis L. 2012. (DEÜ Kütüphanesi) http://site.ebrary.com/lib/deulibrary/detail.action docID=10608725
3. Fundamentals of Clinical Trial. Friedman LM, Furberg CD, DeMets DL. 2010. (DEÜ Kütüphanesi) http://link.springer.com/book/10.1007%2F978-1-4419-1586-3

Yerli kaynaklar :
1. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler Prof Dr S O Kayaalp 5. Baskı, 2012
2. 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

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


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)

ayse.gelal@deu.edu.tr, Tel: 4123904

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 1 14
Preparations before/after weekly lectures 14 6 84
Preparation for final exam 1 25 25
Preparing assignments 1 25 25
Final 1 2 2
TOTAL WORKLOAD (hours) 150

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9
LO.1545455445
LO.2545455445
LO.3545455445
LO.4544455545
LO.5544554545
LO.6544554545
LO.7544544545
LO.8544544545

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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