COURSE COMPILATION
The course is comprised of various group and one to one sessions to ensure that all learning needs are catered for:

PROTOCOL DEVELOPMENT
GROUP SESSIONS
These sessions form the core activity of this Workshop and allow students to complete the writing of their protocol by applying the knowledge acquired during the Workshop. Students will receive extensive feedback on their trial concepts from designated faculty within assigned groups comprising a maximum of ten students.

MEET YOUR EXPERT
SESSIONS
One-to-one sessions where students will have access to experts providing individual counselling on protocol
related issues and advice on career development.

SMALL GROUP DISCUSSION
SESSIONS
Sessions that focus on topics that are essential to the success of clinical trials and facilitating discussion on and around the difficulties and challenges of a particular type of trial. Attendance to these sessions is limited to maximise interaction and information exchange.

LECTURES AND PANEL
DISCUSSIONS
Presentations by key experts on specific topics will provide participants with an overview of the design and implementation of highquality clinical trials. This will be followed by a panel discussion during which Faculty and students can explore issues raised during the talks in greater depth.
PROGRAMME
10:30-15:00 | Registration |
12:00-14:30 | Lunch |
14:30-15:00 | Welcome and Workshop Overview Chair: Saskia Litière (Belgium) |
15:00-15:50 | Opening Lectures |
15:00-15:30 | Introductory Lecture Session Questions to ask yourself in designing a clinical trial Speaker: Pat LoRusso (USA) |
15:30-15:50 | ESMO magnitude of Clinical Benefit Scale Speaker: Elisabeth De Vries (Netherlands) |
16:00-19:30 | Protocol Development Session 1: Protocol Presentation |
20:00-21:30 | Buffet Dinner |
06:30-08:30 | Breakfast | ||||||||
08:30-09:45 | Lecture Session 1 Chair: Emiliano Calvo (Spain) |
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08:30 | How to critically evaluate clinical trial proposals Speaker: Pat LoRusso (USA) |
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08:40 | Phase I trials of chemotherapy and targeted drugs (how to use phase I thinking to combine therapeutics) (modified due to less first in human study) Speaker: S. Percy Ivy (USA) |
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09:00 | Phase II trials (and trials spanning Phase I and II) Speaker: Mairead McNamara (UK) |
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09:20 | Phase III (and trials spanning Phase II and III)) Speaker: Gabe Sonke (Netherlands) |
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09:40 | Q & A | ||||||||
09:45-10:15 | Coffee Break | ||||||||
10:15-12:00 | Lecture Session 2 Chair: Saskia Litière (Belgium)
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12:00-13:15 | Lunch | ||||||||
13:15-15:45 | Protocol Development Session 2: Review of Concept Sheets & Design Development | ||||||||
15:45-16:00 | Coffee Break | ||||||||
16:00-17:00 | Small Group Discussion Sessions 1-3
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17:00-18:00 | Small Group Discussion Sessions 4-6
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18:00-19:20 | Meet your Expert Session 20 minute consultation slots with any faculty member. Advance sign up is required |
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19:30-20:45 | Dinner | ||||||||
20:45 | Independent Protocol Work |
06:30-08:30 | Breakfast | ||||||
08:30-10:00 | Lecture Session 3 Chair: Elisabeth De Vries (Netherlands)
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10:00-10:15 | Coffee Break | ||||||
10:15-11:05 | Lecture Session 4 Chair: Udai Banerji (United Kingdom)
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12:00-13:15 | Lunch | ||||||
13:15-15:45 | Protocol Development Session 3: Study Outlines | ||||||
15:45-16:00 | Coffee Break | ||||||
16:00-17:30 | Meet your Expert Session 20 minute consultation slots with any faculty member. Advance sign up is required. |
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18:00-21:00 | Group activity and dinner/BBQ | ||||||
21:00 | Independent Protocol Work |
06:30-08:30 | Breakfast | ||||||
08:30-09:30 | Lecture Session 5 Chair: Nadia Harbeck (Germany)
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09:30-09:45 | Coffee Break | ||||||
09:45-11:15 | Lecture Session 6 Chair: Sarah Liptrott (Italy)
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12:00-13:15 | Lunch | ||||||
13:15-15:45 | Protocol Development Session 4: Protocol Development | ||||||
15:45-16:00 | Coffee Break | ||||||
16:00-19:20 | Independent Protocol Work | ||||||
16:00-17:00 | Small Group Discussion Sessions 7&8
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17:00-18:00 | Small Group Discussion Sessions 9&10
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18:00-19:30 | Meet your Expert Session | ||||||
19:30-20:30 | Dinner | ||||||
20:30 | Independent Protocol Work |
06:30-08:30 | Breakfast | ||||||||
08:30-09:30 | Lecture Session 7 Chair: Gwenael Le Teuff (France)
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09:45-10:15 | Coffee Break | ||||||||
10:15-11:55 | Lecture Session 8 Chair: Jordi Rodon (USA)
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12:00-13:00 | Lunch | ||||||||
13:00-15:30 | Protocol Development Session 5: Challenges and Feasibility | ||||||||
15:30-16:00 | Coffee Break | ||||||||
16:00-18:00 | Meet your Expert Session | ||||||||
18:00-19:00 | Independent Protocol Work | ||||||||
19:00-20:00 | Dinner | ||||||||
20:00 | Independent Protocol Work |
06:30-08:30 | Breakfast |
08:30-09:00 | Closing Lecture Session Chair: Emilliano Calvo (Spain)Translating cancer research into targeted therapeutics Speaker: Johann De Bono (United Kingdom) |
09:00-09:15 | Coffee Break |
09:30-11:00 | Mock IRB presentations Fellows pitch their protocols to other faculty |
11:00-12:00 | Protocol Development Session 6: Post-Protocol Management |
12:00-13:00 | Lunch |
13:00-18:00 | Independent Protocol Work |
18:00 | FINAL PROTOCOL DUE |
20:00-20:30 | Farewell Reception and awards
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20:30 | Gala Dinner |
06:30-09:30 | Breakfast |
04:30-11:00 | Departures |
*Programme subject to change