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Workshop Programme

 

Please be advised that the Workshop Programme could be subject to change.

 

Saturday 16 June 2018

   
  Arrivals  - Faculty & Fellows
   
12:00 – 15:45 Registration
   
12:00 - 14:30 Lunch
   
14:30 - 16:00 Independent Protocol Work 
   
15:15 - 16:00 1st Faculty Meeting
   
16:00 - 16:30
Welcome and Workshop Overview
   
16:30 - 17:00 Keynote Lecture: Topic to be confirmed
   
17:00 - 17:30
Introductory Lecture Session: Questions to ask yourself in designing a clinical trial
   
17:30 - 20:00 Protocol Development Session 1: Protocol Presentation
Faculty and students gather in the Lounge and go to their assigned PDG breakout room.

Students present their study concept using the presentation template provided. Faculty and students then discuss the protocol concept sheet and the single key question for each study concept. 
   
20:00 - 20:30 Welcome Reception
   
20:30 - 23:00 Dinner
   
23:00 Daily Programme Evaluation Due
 
 
 

Sunday 17 June 2018

06:30  - 08:30 Breakfast
   
08:30 - 10:00 Lecture Session 1
08:30 Phase I trials of chemotherapy and targeted drugs
09:00 Phase II trials (+ trials spanning phase I & II)
09:30 Phase III trials (+ trials spanning phase II & III)
   
10:00 - 10:15 Coffee Break
   
10:15 - 12:15 Lecture Session 2
10:15 Basic biostatistics for the clinical trialist (part I)
10:45 Basic biostatistics for the clinical trialist (part II)
11:15 Choosing and measuring endpoints in clinical trials
11:45 Immunotherapy trials 
   
12:15 - 13:15 Lunch
   
13:15 - 15:45 Protocol Development Group Session 2: Review of Concept Sheets & Design Development
Faculty continue to guide students to complete their protocol concept sheets. An overall study design is developed that meets the established objective. This includes selection of appropriate endpoints and target population.
   
15:45 - 16:00 Coffee Break
   
16:00 - 17:00 Small Group Discussion Sessions 1-4***
SGD 1 Practical aspects of studies involving laboratory biomarkers
SGD 2 Randomised phase II trials
SGD 3 Health economics and health technology assessment
SGD 4 Software for sample size computation: How do I calculate my phase III trial?
   
17:00 - 18:30 Small Group Discussion Sessions 5-8***
SGD 5 Phase I trial endpoints, novel designs
SGD 6 Biomarker-based trial designs: From early adaptive to phase III
SGD 7  Interim Analysis
SGD 8 Software for sample size computation: How do I calculate my single arm phase II trial?
***Advance sign-up on Fellows Room is required as space is limited to 15 pax
   
18:00 - 19:40 Meet your Expert Session 1
  20 minute consultation slots with any Faculty member. Fellows may use these slots to address specific protocol queries at any time. They can also discuss career-related issues but these discussions should be held towards the end of the Workshop after most fellows have completed, or nearly completed, their protocols. Advance sign-up on Fellows Room is required.
   
19:40 - 20:45 Dinner
   
20:45 Independent Protocol Work
   
22:00 Protocol Concept Sheet Due


23:00 Daily Programme Evaluation Due
   
   
   

Monday 18 June 2018

06:30 - 08:30 Breakfast
   
08:30 - 10:00 Lecture Session 3
08:30 Integrating surgery in multi-modality trials – implications for design, endpoints and quality control
09:00 Special considerations in combined treatment trials (chemo-radiation) – implications for design, endpoints and quality control
09:30 Imaging biomarkers – implications for design endpoints and quality control
   
10:00 - 10:15 Coffee Break
   
10:15 - 11:45 Lecture Session 4 
10:15 Prognostic and predictive markers for patient selection 
10:45 Liquid biopsies and CTCs
11:15 Biomarkers & adaptive clinical trial design 
   
11:45 - 12:30 2nd Faculty Meeting
   
12:00 - 13:15
Lunch
   
13:15 - 15:45 Protocol Development Session 3: Study Outlines
  Concept sheets are returned to students. The study concept should now be translated into a short study outline that details the trial objectives, statistical design, target population, biomarkers and translational research opportunities.
   
15:45 - 16:00 Coffee Break
   
16:00 - 18:00 Meet your Expert Session 2
20 minute consultation slots with any Faculty member. Fellows may use these slots to address specific protocol queries at any time. They can also discuss career-related issues but these discussions should be held towards the end of the Workshop after most fellows have completed, or nearly completed, their protocols. Advance sign-up on Fellows Room is required.
   
18:15 - 19:45 Team Building Activity
   
19:45 - 20:45 Dinner
   
20:45 Independent Protocol Work
   
22:00 Statistical Section Due


23:00  Daily Programme Evaluation Due
   
   
   

Tuesday 19 June 2018

06:30 - 08:30 Breakfast
   
08:30 - 09:30 Lecture Session 5 
08:30 Role of pharmacokinetics & pharmacodynamics in clinical trials 
09:00 Overview of dose finding designs for phase I clinical trials 
   
09:30 - 09:45 Coffee Break
   
09:45 - 11:15 Lecture Session 6
09:45 Ethics and patient participation in cancer clinical trials 
10:15 Patient-oriented endpoints/QoL 
10:45 Pragmatic vs non-pragmatic trials: Addressing economic aspects of clinical trials 
   
11:15 - 12:15 Group Photos
   
12:15 - 13:15 Lunch
   
13:15 - 15:45 Protocol Development Session 4: Protocol Development
  Protocols are developed based on the outline with further details on eligibility criteria, evaluations schedule, treatment regimen and data/sample collection.
   
15:45 - 16:00 Coffee Break
 
Independent Protocol Work in parallel to Small Group Discussion Sessions and Meet your Expert Sessions
   
16:00 - 19:20 Independent Protocol Work
   
16:00 - 17:00 Small Group Discussion Session 9-12*** 
SGD 9 Radiotherapy trials
SGD 10 Biobanking and set-up of translational research
SGD 11 Pharmacokinetic - pharmacodynamic studies, pharmacogenomics and success for drug development 
SGD 12 Translational and practical aspects of immunotherapy trials 
   
17:00 - 18:00 Small Group Discussion Session 13-15***
SGD 13 Software for sample size computation: How do I calculate my randomised phase II trial?
SGD 14 Combination trials
SGD 15 Negotiating a contract with industry
***Advance sign-up on Fellows Room is required as space is limited to 20 pax 
   
18:00 - 19:20 Meet your Expert Session 3
  20 minute consultation slots with any Faculty member. Fellows may use these slots to address specific protocol queries at any time. They can also discuss career-related issues but these discussions should be held towards the end of the Workshop after most fellows have completed, or nearly completed, their protocols. Advance sign-up on Fellows Room is required.
   
19:20 – 20:30  Dinner
   
20:30 Independent Protocol Work
   
22:00 Draft Protocol Due


23:00 Daily Prorgamme Evaluation Due
   
   
   

Wednesday 20 June 2018

06:30 - 08:30 Breakfast
   
08:30 - 09:30  Lecture Session 7
08:30 Research integrity and its effects on drug development 
09:00 Data and safety monitoring and independent study review - regulatory and other practical issues 
   
09:30 - 10:00 Coffee Break
   
10:00 - 11:00 Lecture Session 8
10:00 Common errors in statistics
10:30 Practical implementations of a clinical trial
   
11:00 - 12:15 Independent Protocol Work
   
12:15 - 13:15 Lunch
   
13:15 - 15:45 Protocol Development Session 5: Challenges and Feasibility
Protocol finalisation and discussion on challenges, feasibility and informed consent.
   
15:45 - 16:15 Coffee Break
   
15:45 - 16:45 Workshop Directors’ Meeting 
   
17:00 - 19:00 Meet your Expert Session 4
  20 minute consultation slots with any Faculty member. Fellows may use these slots to address specific protocol queries at any time. They can also discuss career-related issues but these discussions should be held towards the end of the Workshop after most fellows have completed, or nearly completed, their protocols. Advance sign-up on Fellows Room is required.
   
19:00 - 20:00 Dinner
   
20:00 Independent Protocol Work
   
22:00 Draft Informed Consent Forms Due


23:00 Daily Programme Evaluation Due
   
   
   

Thursday 21 June 2018

06:30 - 08:30 Breakfast
   
08:30 - 09:30
Closing Lecture Session 
Translating cancer research into targeted therapeutics 
   
09:30 - 09:45 Coffee Break
   
09:45 – 12:45 Protocol Development Session 6
  Final protocol discussions about various post-protocol implementation aspects (practical issues, patient accrual, funding etc.). 

If possible, students present their final protocols to faculty members of other PDGs (mock IRB review). This exercise is not mandatory and will depend on each PDG and their progress.  

   
12:45 - 13:45 Lunch
   
13:45 - 18:00 Independent Protocol Work
   
14:00 - 15:00 3rd Faculty Meeting
   
18:00 Final Protocol Due
   

Daily Programme Evaluation Due
   
  General Evaluation Due
   
20:00 - 20:30 Farewell Reception and Highlights
   
20:30 Dinner & Award Presentation
  Outstanding Mentor Award 
Outstanding Biostatistician Mentor Award
Innovative Protocol Award
   
   
   

Friday 23 June 2018

06:30 - 09:30 Breakfast
   

 

Departures - Faculty & Fellows
   
  Shuttles from Woudschoten Hotel to Amsterdam Schipol Airport

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