Programme2018-12-04T07:26:39+00:00

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 i thin 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
14:30-16:00 Independent Protocol Work
16:00-16:30 Welcome and Workshop Overview
16:30-17:00 Introductory Lecture Session
Questions to ask yourself in designing a clinical trial
17:00-20:00 Protocol Development Session 1: Protocol Presentation
20:00-22:30 Buffet Dinner
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 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 Session 2: Review of Concept Sheets & Design Development
15:45-16:00 Coffee Break
16:00-17:00 Small Group Discussion Sessions 1-4

SGD 1: Small Group Discussion Sessions 1-4
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?
17:00-18:00 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?
18:00-19:40 Meet your Expert Session
19:40-20:45 Dinner
20:45 Independent Protocol Work
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
12:00-13:15 Lunch
13:15-15:45 Protocol Development Session 3: Study Outlines
15:45-16:00 Coffee Break
16:00-18:00 Meet your Expert Session
18:15-19:45 Team Building Activity
19:45-20:45 Dinner
20:45 Independent Protocol Work
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 Multi-institutional trials through collaborative groups
12:15-13:15 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 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 Sessions 13-15

SGD 13: Trial Budgets
SGD 14: Combination trials
SGD 15: Negotiating a contract with industry
18:00-19:20 Meet your Expert Session
19:20-20:30 Dinner
20:30 Independent Protocol Work
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 Practicalities and implementation 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
15:45-16:00 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
Translating cancer research into targeted therapeutics
09:00-09:15 Coffee Break
09:15-12:15 Protocol Development Session 6: Post-Protocol Management
12:15-13:15 Lunch
13:15-18:00 Independent Protocol Work
18:00 FINAL PROTOCOL DUE
20:00-20:30 Farewell Reception
20:30 Dinner & Award Presentation
Outstanding Mentor Award
Outstanding Biostatistician Mentor Award
Innovative Protocol Award
06:30-09:30 Breakfast
04:30-11:00 Departures