COURSE COMPILATION

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

Session 1

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.

session 2

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.

session 3

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.

session 4

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)
08:30 How to critically evaluate clinical trial proposals
Speaker: Pat LoRusso (USA)
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)
09:00 Phase II trials (and trials spanning Phase I and II)
Speaker: Mairead McNamara (UK)
09:20 Phase III (and trials spanning Phase II and III))
Speaker: Gabe Sonke (Netherlands)
09:40 Q & A
09:45-10:15 Coffee Break
10:15-12:00

Lecture Session 2
Chair: Saskia Litière (Belgium)

10:15 Endpoints 1: Choosing and measuring endpoints in clinical trials
Speaker: Viktor Moreno (Spain)
10:40 Endpoints 2: where does Immunotherapy trials differ
Speaker: Christophe Massard (France)
11:05 Basic biostatistics for the clinical investigator (part I)
Speaker: Susan Hilsenbeck (USA)
11:30 Basic biostatistics for the clinical investigator (part II)
Speaker: Susan Hilsenbeck (USA)
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

SGD 1: Radiotherapy trials
Chair: Jan Bussink (Netherlands)
Faculty: Rafal Dziadziuszko (Poland)
SGD 2: Surgical Trials
Chair: Maria Joao Cardoso (Portugal)
Faculty: to be announced
SGD 3: Phase I trial endpoints, novel designs, single agents and combinations
Chair: Emiliano Calvo (Spain)
Faculty: Jordi Rodon (USA)
Faculty: Johann De Bono (UK)
17:00-18:00

Small Group Discussion Sessions 4-6

SGD 4: Software for sample computation
Chair: Susan Hilsenbeck (USA)
Faculty: Sarah Brown (United Kingdom)
Faculty: Francesca Michielin (Switzerland)
Faculty: to be announced
SGD 5: Biomarkers based trial designs
Chair: Nadia Harbeck (Germany)
Faculty: Nuria Porta (United Kingdom)
Faculty: Victor Moreno (Spain)
SGD 6: Immunotherapy trials
Chair: Elisabeth de Vries (Netherlands)/Gabe Sonke (Netherlands)
Faculty: Christophe Massard (France)
Faculty: Yu Shyr (USA)
18:00-19:20 Meet your Expert Session
20 minute consultation slots with any faculty member. Advance sign up is required
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)

08:30 Overview of RECIST and iRECIST
Speaker: Elisabeth De Vries (Netherlands)
08:55 Case presentations
Speaker: Emiliano Calvo (Spain)
09:20 When to use different Imaging tools in clinical trials (issue of radiation burden)
Speaker: Wim Oyen (Netherlands)
10:00-10:15 Coffee Break
10:15-11:05 Lecture Session 4
Chair: Udai Banerji (United Kingdom)

10:15 Role of pharmacokinetics and pharmacodynamics in clinical trials
Speaker: Johann De Bono (UK)
10:40 Overview of dose finding designs for phase I clinical trials
Speaker: Yu Shyr (USA)
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.
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)

08:30 Prognostic and predictive markers for patient selection
Speaker: Henrik Arkenau (United Kingdom)
08:55 Liquid biopsies and CTC’s
Speaker: Francois Bidard (France)
09:20 Q & A
09:30-09:45 Coffee Break
09:45-11:15

Lecture Session 6
Chair: Sarah Liptrott (Italy)

09:50 Ethics and patient participation in cancer clinical trials
Speaker: Sarah Liptrott (Italy)
10:15 Patient-orientated endpoints/QoL
Speaker: Murielle Mauer (Belgium)
10:45 Team Photo
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

SGD 7: Small Group Discussion 7: Practical aspects of studies involving laboratory biomarkers
Chair: Johann De Bono (UK)
Faculty: Francois Bidard (France)
Faculty: Yu Shyr (USA)
SGD 8: Small Group Discussion 8: The art of randomisation
Chair: Matthew Sydes (United Kingdom)
Faculty: Sarah Brown (United Kingdom)
17:00-18:00

Small Group Discussion Sessions 9&10

SGD 9: Small Group Discussion 9: Biobanking and set-up of translational research
Chair: Christophe Massard (France)
Faculty: Judith Bovee (Netherlands)
SGD 10: Small Group Discussion 10: Negotiating a contract with industry
Chair: Henrik Arkenau (United Kingdom)
Faculty: Udai Banerji (United Kingdom)
Faculty: Saskia Litière (Belgium)
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)

08:30 Garbage in, Garbage out (necessary components to ensure quality protocol results)
Speaker: S. Percy Ivy
08:55 Data and safety monitoring and independent study review regulatory and other practical issues
Speaker: Mathew Sydes (United Kingdom)
09:20 Common errors in statistics
Speaker: Saskia Litière (Belgium)
09:45-10:15 Coffee Break
10:15-11:55 Lecture Session 8
Chair: Jordi Rodon (USA)

10:15 Practicalities and implementation of a clinical trial
Speaker: Jessica Menis (Italy)
10:40 Multi-institutional trials through collaboration groups
Speaker: D. Lacombe (Belgium)
11:05 Resources for a successful clinical trial
Speaker: Jordi Rodon (USA)
11:30 Regulatory requirements in cancer drug development and approval process
Speaker: Ralf Herold (Netherlands)
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: Elizabeth Eisenhauer (Canada)

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

  • Outstanding Mentor Award
  • Outstanding Biostatistician Award
  • Innovative Protocol Award
20:30 Gala Dinner
06:30-09:30 Breakfast
04:30-11:00 Departures

*Programme subject to change