ASCO International Clinical Trials Workshop. May 7-8, Lazzoni Hotel Halic - Istanbul, Turkey

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1 ASCO International Clinical Trials Workshop May 7-8, 2016 Lazzoni Hotel Halic - Istanbul, Turkey

2 Saturday, 7 May Welcome and Introduction Representatives of ASCO, NCI and Turkish Society of Medical Oncology Session I - Overview of Cancer Clinical Trials Chair:, Ahmet Özet Epidemiology of cancer in Turkey and Eastern Mediterranean countries Murat Gültekin Director, Cancer Control Department, Turkish Ministry of Health Clinical trials in Turkey and neighboring countriesimportance and main challenges (academic perspective) Mehmet Artaç Clinical trials in Turkey - importance and main challenges (government perspective) Hakkı Gürsöz Director, Clinical Trials Department, Turkish Ministry of Health Funding sources of cancer clinical trials (industry perspective) Fatih Özdener Industry Panel / Discussion Coffee Break

25 Clinical trials in Turkey and neighboring countriesimportance and main challenges (academic perspective) Mehmet Artaç 09.25-09.

3 Session II - Clinical Trial Design and Methodology - I Chair: Gail Eckhart, Pınar Saip How to identify and ask a research question Phase I protocol designs Gail Eckhart Phase II protocol designs Gail Eckhart Statistical issues in phase I and II trials Matt Sydes Panel / Discussion Lunch

30 Phase I protocol designs Gail Eckhart 11.30-11.

4 Session III - Clinical Trial Design and Methodology II Chair: Matt Sydes, Hakan Akbulut Phase III protocol designs Statistical issues in phase III trials Matt Sydes International standards of informed consent and good Serdar Turhal Which endpoints in clinical trials? (response rate, PFS, OS etc), tog 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 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 Summary of progress and problems from the workshops Adjourn

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.

5 Sunday, 8 May 2016 Session V Chair:, Mustafa Benekli Alternative types of clinical research: observational studies, quality of life, cost-effectiveness, prognosis Principles of ethics in clinical research Fulden Yumuk Responsibilities of the study team (including ethical responsibilites) Gail Eckhardt Site management, monitoring and audit in clinical trials (including ethical responsibilities) Christine de Balincourt Discussion Coffee Break

20 Principles of ethics in clinical research Fulden Yumuk 09.20-09.

6 Sunday, 8 May 2016 Session VI Chair: Gail Eckhardt, Hüseyin Abalı Adverse events in clinical trials Christine de Balincourt How can you write a protocol? Matt Sydes Publishing and presenting your research findings - How to write a clear abstract and paper - How to select a relevant journal Clinical benefit / rational and cost-effective use of drugs Alex Enui Discussion Lunch Reading the literature on clinical trials with a critical eye: learning from the mistakes of others

40 Publishing and presenting your research findings - How to write a clear abstract and paper - How to select a relevant journal 11.40-12.

7 Session VII - Interactive Groups - II Workshop with small groups (fellows, etc.) on the tables for developing clinical trial protocols 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 Presentation of protocols by the small groups Closing remarks End of the workshop - certification

Gökhan Demir, Saadettin Kılıçkap, İrfan Çiçin, Mustafa Benekli, Serdar Turhal, Hakan Bozcuk, Ahmet Demirkazık, Fulden Yumuk, Mustafa Erman, Hakan

8 COURSE PRESIDENTS Dr. 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. Dr. Serdar Turhal Dr. Fulden Yumuk

İrfan Çiçin Dr. Gökhan Demir Dr. Ahmet Demirkazık Dr. Gail Eckhardt Dr. Alex Enui Dr. Mustafa Erman Dr. Murat Gültekin Dr.

June 27, 2015 Radisson Blu Hotel Sisli - Istanbul

5 June 27, 2015 Radisson Blu Hotel Sisli - Istanbul INVITATION On behalf of the Turkish Medical Oncology Society Executive Committee, it th is my pleasure to invite you to join the 6 ASCO-licensed "Best