ASCO
International Clinical
Trials Workshop
May 7-8, 2016
Lazzoni Hotel
Halic - Istanbul, Turkey
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Saturday, 7 May 2016
08.30 - 08.45
Welcome and Introduction
Representatives of ASCO, NCI and Turkish Society of Medical Oncology
Session I - Overview of Cancer Clinical Trials
Chair: Ian Tannock, Ahmet Özet
Murat Gültekin
08.45 - 09.05
Epidemiology of cancer in Turkey and Eastern
Mediterranean countries
09.05 - 09.25
Clinical trials in Turkey and neighboring countriesimportance and main challenges (academic perspective)
Director,
Cancer Control
Department,
Turkish Ministry of
Health
Mehmet Artaç
Hakkı Gürsöz
09.25 - 09.45
Clinical trials in Turkey - importance and main challenges
(government perspective)
Director,
Clinical Trials
Department,
Turkish Ministry of
Health
Funding sources of cancer clinical trials
(industry perspective)
Fatih Özdener
09.45 - 10.05
10.05 - 10.30
Panel / Discussion
10.30 - 10.50 Coffee Break
Industry
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Session II - Clinical Trial Design and Methodology - I
Chair: Gail Eckhart, Pınar Saip
10.50 - 11.10
How to identify and ask a research question
Ian Tannock
11.10 - 11.30
Phase I protocol designs
Gail Eckhart
11.30 - 11.50
Phase II protocol designs
Gail Eckhart
11.50 - 12.10
Statistical issues in phase I and II trials
Matt Sydes
12.10 - 12.30
Panel / Discussion
12.30 - 13.30 Lunch
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Session III - Clinical Trial Design and Methodology – II
Chair: Matt Sydes, Hakan Akbulut
10.50 - 11.10
Phase III protocol designs
Ian Tannock
11.10 - 11.30
Statistical issues in phase III trials
Matt Sydes
11.30 - 11.50
International standards of informed consent and good
Serdar Turhal
11.50 - 12.10
Which endpoints in clinical trials?
(response rate, PFS, OS etc), tog
Ian Tannock
12.30 - 13.30 Coffee Break
Session IV - Interactive Groups - I
Workshop with small groups (fellows, etc) on the tables for discussing their
hypotheses and starting a clinical trial protocol
15.10 - 16.40 Group 1, 2, 3, 4, 5
Facilitators: International faculty, Ahmet Özet, Melih Cem Börüban, Pınar Saip,
Mahmut Gümüş, Kadri Altundag, Hüseyin Abalı, Gökhan Demir, Saadettin Kılıçkap,
İrfan Çiçin, Mustafa Benekli, Serdar Turhal, Hakan Bozcuk, Ahmet Demirkazık,
Fulden Yumuk, Mustafa Erman, Hakan Akbulut, Mehmet Artaç, Mutlu Hayran
16.40 - 17.00
17.00
Summary of progress and problems from the workshops
Adjourn
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Sunday, 8 May 2016
Session V
Chair: Ian Tannock, Mustafa Benekli
08.30 - 09.00
Alternative types of clinical research: observational studies,
quality of life, cost-effectiveness, prognosis
Ian Tannock
09.00 - 09.20
Principles of ethics in clinical research
Fulden Yumuk
09.20 - 09.40
Responsibilities of the study team
(including ethical responsibilites)
Gail Eckhardt
09.40 - 10.00
Site management, monitoring and audit in clinical trials
(including ethical responsibilities)
Christine de
Balincourt
10.00 - 10.20
Discussion
10.20 - 10.40 Coffee Break
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Sunday, 8 May 2016
Session VI
Chair: Gail Eckhardt, Hüseyin Abalı
10.40 - 11.00
Adverse events in clinical trials
Christine de
Balincourt
11.00 - 11.20
How can you write a protocol?
Matt Sydes
Publishing and presenting your research findings
11.20 - 11.40
- How to write a clear abstract and paper
- How to select a relevant journal
11.40 - 12.00
Clinical benefit / rational and cost-effective use of drugs
12.00 - 12.30
Discussion
Ian Tannock
Alex Enui
12.30 - 13.30 Lunch
13.30 - 14.00
Reading the literature on clinical trials with a critical eye:
learning from the mistakes of others
Ian Tannock
TURKISH
SOCIETY OF
MEDICAL
ONCOLOGY
Session VII - Interactive Groups - II
Workshop with small groups (fellows, etc.) on the tables for developing clinical
trial protocols
14.00 - 15.30 Group 1, 2, 3, 4, 5
Facilitators: International faculty + Ahmet Özet, Melih Cem Börüban, Pınar Saip,
Mahmut Gümüş, Kadri Altundag, Hüseyin Abalı, Gökhan Demir, Saadettin Kılıçkap,
İrfan Çiçin, Mustafa Benekli, Serdar Turhal, Hakan Bozcuk, Ahmet Demirkazık,
Fulden Yumuk, Mustafa Erman, Hakan Akbulut, Mehmet Artaç, Mutlu Hayran
15.30 - 16.30
Presentation of protocols by the small groups
16.30
Closing remarks
16.45
End of the workshop - certification
COURSE PRESIDENTS
Dr. Ian Tannock
Dr. Melih Cem Börüban
Dr. Mehmet Artaç
SCIENTIFIC COMMITTEE
Dr. Hüseyin Abalı
Dr. Hakan Akbulut
Dr. Kadri Altundağ
Dr. Mehmet Artaç
Dr. Christine De Balincourt
Dr. Mustafa Benekli
Dr. Hakan Bozcuk
Dr. Melih Cem Börüban
Dr. İrfan Çiçin
Dr. Gökhan Demir
Dr. Ahmet Demirkazık
Dr. Gail Eckhardt
Dr. Alex Enui
Dr. Mustafa Erman
Dr. Murat Gültekin
Dr. Mahmut Gümüş
Dr. Hakkı Gürsöz
Dr. Mutlu Hayran
Dr. Saadettin Kılıçkap
Dr. Ahmet Özet
Dr. Pınar Saip
Dr. Matt Sydes
Dr. Ian Tannock
Dr. Serdar Turhal
Dr. Fulden Yumuk
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ASCO International Clinical Trials Workshop