I N T E R N A T I O N A L. Clinical Trials. Workshop MAY 2017 ATHENS GREECE. Crowne Plaza Hotel

Transcript

1 19-20 MAY 2017 ATHENS GREECE Crowne Plaza Hotel S c i e n t i f i c P r o g r a m

2 C o m m i t t e e s Organising Committee President Vice President Gen. Secretary Secretary Treasurer Members I. Varthalitis G. Aravantinos G. Mountzios Z. Saridaki A. Ardavanis E. Galani Ι. Boukovinas Scientific Committee A. Eniu V. Golfinopoulos A. Goudopoulou Ε. Linardou D. Mavroudis G. Mountzios G. Pentheroudakis A. Psyrri E. Razis E. Saloustros M. Sydes I. Tannock S. Romboli MAY 2017 ATHENS GREECE 3

3 S c i e n t i f i c P r o g r a m Friday, May 19 th, 2017 Session I - Overview State of Research in Greece Past and Present E. Razis Translational Research D. Mavroudis Discussion Clinical Trial Development in Greece G. Pentheroudakis Discussion Patient accrual-cultural issues, Patient groups E. Linardou Discussion Coffee Break Session II - Design and Methodology Conceiving an idea and translating it into a research question V. Golfinopoulos Discussion Phase I & II Clinical Trial Design I. Tannock 4CROWNE PLAZA HOTEL Discussion Phase III Clinical Trial Design V. Golfinopoulos Discussion Statistics and Trial Design M. Sydes Discussion Lunch Special Τrial Designs I. Tannock Discussion

4 The research team choosing Sites Α. Psyrri Discussion Cooperative groups (national and international) A. Eniu Discussion Value and Clinical Benefit Studies A. Eniu, I. Tannock Discussion Coffee Break Session III - Break out Sessions Which design for which question: Fundamental biostatistical concerns. Clinical Benefit and Cost Effectiveness (Value Framework) A. Eniu Observational and QOL studies I. Tannock Biomarkers and translational research V. Golfinopoulos Smaller populations M. Sydes Trial design: learning through a published paper I E. Razis Trial design: learning through a published paper II G. Mountzios MAY 2017 ATHENS GREECE 5

5 Saturday, May 20 th, 2017 Session IVA - Logistics ICF / CRF Technology Novel ways that can assist in data capture S. Romboli Discussion GCP/ Ethics and the Informed Consent E. Saloustros Discussion Funding and Budget V. Golfinopoulos Discussion Session IVB - Running the Protocol Regulations and SAE Safety in clinical trials A. Goudopoulou Discussion Site Monitoring-Audits V. Golfinopoulos Discussion Coffee Break 6CROWNE PLAZA HOTEL Session V - Publication Presenting, Writing and Publishing G. Mountzios Discussion What can go wrong: Bias, under powered studies, early stopping etc Discussion M. Sydes Critical Evaluation of the literature I. Tannock Discussion

6 Data Sharing M. Sydes Discussion Lunch Session VI - Break out Sessions Clinical Benefit and Cost Effectiveness (Value Framework) A. Eniu Observational and QOL studies I. Tannock Biomarkers and translational research V. Golfinopoulos Smaller populations M. Sydes Trial design: learning through a published paper I E. Razis Trial design: learning through a published paper II G. Mountzios Presentations by the groups Discussion & Closure MAY 2017 ATHENS GREECE 7

7 Fa c u l t y Eniu Alexandru MD, PhD, Cancer Institute Ion Chiricuta, Department of Breast Tumors Head of the Day Hospital Unit, Cluj-Napoca, Romania Golfinopoulos Vassilios EORTC, Medical Director, Brussels, Belgium Goudopoulou Athina Clinical Safety Coordinator/ Coordinator, HeCOG Data Office, Athens, Greece Linardou Eleni MD, PhD, Consultant Medical Oncologist, Ass. Director, 1 st Oncology Department, Metropolitan Hospital, Athens, Greece Mavroudis Dimitrios Professor Of Oncology, Medical School, Univeristy of Crete, Greece Mountzios Giannis MD, MSc, PhD, Medical Oncologist, 251 Air Force General Hospital, Athens, Greece Pentheroudakis Georgios Associate Professor Of Oncology, Medical School, University of Ioannina, Greece Psyrri Amanda Ass. Professor, Chief of Medical Oncology, 2 nd Department of Internal Medicine, University General Hospital "Attikon" Athens, Greece Razis Evangelia MD, PhD, Medical Oncologist, Director 3 rd Oncology Department, Hygeia Hospital, Athens, Greece 8CROWNE PLAZA HOTEL Saloustros Emmanouil MD, DSc. Oncology Unit, General hospital of Heraklion Venizelio. Greece Sydes Matt Reader in, MRC Unit at UCL, Institute of & Methodology, London, UK Tannock Ian CM, MD, PhD, DSc, Emeritus Professor of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Canada Romboli Sophia BSc PhD, Country Manager, Zeincro Hellas SA

8 G e n e r a l I n f o r m a t i o n Organized by: American Society of Clinical Oncology Hellenic Society of Medical Oncology Date: May 2017 Venue: Crowne Plaza Hotel 50, Mihalakopoulou Av , Athens, Greece Tel Secretariat: E.T.S. Events & Travel Solutions S.A. 154 El.Venizelou, N.Smirni Tel.: Fax: ets@otenet.gr, ets@events.gr CROWNE PLAZA HOTEL 10

9 N o t e s MAY 2017 ATHENS GREECE 11

10 19-20 MAY 2017 ATHENS GREECE Crowne Plaza Hotel