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Workshop Programme

 

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

 

Saturday 17 June 2017

 

12:00 – 16:00

Registration

16:45 – 17:15

Welcome and Workshop Overview

17:15 – 17:35

Introductory Lecture Session

 

How to write the basics of your protocol

17:45 – 20:15 

Protocol Development Group Session 1

Students present their study concepts within their assigned Protocol Development Group. Faculty and students discuss the protocol concept sheet and the single key question in each study concept.

Sunday 18 June 2017

 

08:00 – 09:30 

Lecture Session 1

 

Phase I trials of chemotherapy and targeted drugs

 

Phase II trials (+ trials spanning phase I & II

 

Phase III trials (+ trials spanning phase II & III)

10:00 – 12:00 

Lecture Session 2 

 

Basic biostatistics for the clinical trialist (part I)

 

Basic biostatistics for the clinical trialist (part II)

 

Choosing and measuring endpoints in clinical trials

 

Immunotherapy trials 

13:00 – 15:45 

Protocol Development Group Session 2

 

Faculty continue to guide students to complete their protocol concept sheets.

16:15 – 17:15 

Small Group Discussion Sessions 1-3***

SGD 1

Practical aspects of studies involving laboratory biomarkers

SGD 2

Software for sample size computation: How do I calculate my phase II protocol?

SGD 3

Biomarker-based trial designs: From early adaptive to phase III

17:30 – 18:30 

Small Group Discussion Sessions 4-6*** 

SGD 4

Phase I trial endpoints, novel designs

SGD 5 

Randomised Phase II trials 

SGD 6 

Software for sample size computation: How do I calculate my phase III protocol? 

 

***Advance sign-up on Workshop intranet is required as space is limited to 20 pax 

18:30 – 19:30 

Independent Protocol Work 

20:45 – 22:45 

Meet your Expert Session 1

 

Advance sign-up on Workshop intranet is required

20:45 

Independent Protocol Work

Monday 19 June 2017

 

 

Independent Protocol Work 

09:00 – 10:30 

Lecture Session 3 

 

Integrating surgery in multi-modality trials – implications for design, endpoints and quality control 

 

Special considerations in trials of radiation therapy – implications for design, endpoints and quality control 

 

Special considerations in combined treatment trials (chemo-radiation) – implications for design, endpoints and quality control 

10:45 – 12:15 

Lecture Session 4 

 

Prognostic and predictive markers for patient selection 

 

How to implement biomarker questions into statistical design

 

Biomarkers & adaptive clinical trial design 

13:30 – 16:30 

Protocol Development Session 3

 

Faculty and students discuss protocol details. 

16:45 – 19:00 

Independent Protocol Work 

20:30 – 21:30

Meet your Expert Session 2 

 

Advance sign-up on Workshop intranet is required  

Tuesday 20 June 2017

 

 08:30 – 09:30

Lecture Session 5 

 

Role of pharmacokinetics & pharmacodynamics in clinical trials 

 

Innovative methods for dose finding trials (modified toxicity probability interval and model-guided methods): Practical aspects of implementation 

10:00 – 11:30 

Lecture Session 6 

 

Ethics and patient participation in cancer clinical trials 

 

Patient-oriented endpoints/QoL 

 

Pragmatic vs non-pragmatic trials: Addressing economic aspects of clinical trials 

13:00 – 15:30 

Protocol Development Session 4 

16:00 – 18:00

Meet your Expert Session 3 

 

Advance sign-up on Workshop intranet is required 

16:00 – 17:00 

Small Group Discussion Session 7-9*** 

SGD 7 

Radiotherapy trials

SGD 8

Biobanking and set-up of translational research

SGD 9

Pharmacokinetic - pharmacodynamic studies, pharmacogenomics and success for drug development 

 

Small Group Discussion Session 10-12***

SGD 10 

Translational and practical aspects of immunotherapy trials 

SGD 11

Combination trials 

SGD 12

Negotiating a contract with industry 

 

***Advance sign-up on Workshop intranet is required as space is limited to 20 pax 

18:15 – 21.15 

Group Activity 

21:15 

Independent Protocol Work 

Wednesday 21 June 2017

 

08:00 – 09:30

Independent Protocol Work

09:30 – 10:30 

Lecture Session 7 

 

Research integrity and its effects on drug development 

 

Data and safety monitoring and independent study review - regulatory and other practical issues 

11:00 – 12:00 

Lecture Session 8 

 

Common errors in statistics

 

Practical implementations of a clinical trial

13:30 – 16:00 

Protocol Development Session 5 

 

Funding and implementation aspects. 

16:30  

Independent Protocol Work 

Thursday 22 June 2017

 

08:00 – 09:15 

Independent Protocol Work 

09:15 – 09:45 

Closing Lecture Session 

 

Translating cancer research into targeted therapeutics 

10:00 – 13:00 

Protocol Development Session 6

14:00

Independent Protocol Work 

Friday 23 June 2017

 

 

Departures 

 

Shuttles to Amsterdam Airport 

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