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A CROS Academy course
Statistical Considerations
in Oncology Studies
Hotel Eden Wolff
Arnulfstraße 4 –
80335 München,
Germany
Tuesday, 28th April 2015
9:00 – 17:00
Course conducted in German language, course material in English
FOR ADDITIONAL INFORMATION:
+39 045 820 26 66 [email protected]
Statistical Considerations
in Oncology Studies
A CROS Academy course
Introduction
Cancer is among the top 10 leading causes of death in the world and accounts for over 8.2 million deaths.
Oncology drug development consumes an average of seven years in clinical evaluation and yields a discouraging success rate: only 7 % of oncology agents entering Phase I gain marketing approval.
What makes oncology so unique?
It is not a single characteristic which makes Oncology different, but rather the simultaneous occurrence of:
• Many etiologies
• The importance of disease sub-types and/ or genotypes.
• The use of treatment combinations.
• Different modes of action of drugs.
• Regimen modifications during treatment.
• The high impact of the disease on patient life.
• The high costs of treatment.
• Slow recruitment.
• Long timelines to reach clinical endpoints.
How can a statistician help drug developers focus on the right dose and the right disease in the right
patients as early in the research process as possible?
Part I – Requirements for Successful Phase I and II Studies
Phase I and II product development lays the foundation for successful Phase III studies. Particularly in
oncology, the heterogeneity of the disease can influence the planning and of clinical trials. In this course,
the main influential factors in oncology studies will be discussed, as well as the challenge of objective criteria and surrogate markers. New study designs make it possible to minimize the number of patients in the
early stages, and this concept will be presented.
Part II – Statistical Methods for Early Detection in Phases II and II
During Phase III development, efficacy of the drug should be confirmed. Many new products have to find a
very specific mechanism of effectiveness, so therefore subpopulations are necessary. Flexible study
designs that allow early termination and the use of fewer patients can be a successful solution for determining clinical efficacy. The advantages and disadvantages of flexible designs will be discussed in Part II.
After this course, you should be able to:
• Realize the challenges of oncology trials
• Discuss the adaptations possible in a trial
• Realize the potential benefits/risks of adaptive trials
From whom is this course designed?
• Heads of Operations with limited or no Statistics knowledge
• Heads of Oncology Clinical Research
• Medical Directors
• Clinical Professionals in Pharmaceutical, Biotech or CRO companies
• Biostatisticians with limited knowledge of adaptive trial design
Statistical Considerations
in Oncology Studies
A CROS Academy course
About the instructor
Thomas Zwingers
Thomas Zwingers is the Senior Director of Consultancy Services for CROS NT, a global CRO with offices in
Italy, Germany and the United Kingdom. He has been working in the clinical trial environment since 1980 in
project team management and statistical analysis. Thomas specializes in statistical analyses and reporting
with particular expertise in Adaptive Trial Design. He also serves as Chairman of the Clinical Data
Consultancy Team, a prominent group of statisticians who offer consultancy on statistical challenges
facing the clinical trial environment. Thomas has written and collaborated on over 100 publications
throughout his career.
Agenda
09:00 – 09:15
Registration
09.15 – 09.45
Why is Oncology special - introduction
09:45 – 10:15
Study Designs in Oncology research
10:15 – 10:45
Overview of Statistical Methods
10:45 – 11:00
Coffee Break
11:00 – 12:30
Statistical Considerations for Oncology Studies - Early Phase Studies
12:30 – 13:30
Lunch
13:30 – 14:15
Statistical Considerations for Oncology Studies - Late Phase Studies
14:15 – 15:00
Considerations for Interim Analyses
15:00 – 15:15
Coffee Break
15:15 – 16:30
Hand-on Exercise on a Design in a Phase II/III trial
16:30 – 17:00
Q&A
CROS NT & CROS Academy
CROS NT & CROS Academy
CROS NT is an international CRO specialized in clinical data services. Services include Biostatistics (methodology,
programming and analysis), Data Management, Medical Writing, Consultancy, Life Science Technology and Training.
CROS NT offers value to Sponsors of clinical trials by combining statistical and data management expertise with
innovative technology solutions (ePRO, EDC, CTMS, eLearning).
Building off CROS NT’s strong statistical heritage and expertise, CROS Academy provides a series of webinars, on-site
courses and eLearning from top statisticians within the CROS NT organization.
A CROS Academy course
Statistical Considerations
in Oncology Studies
Registration fee: € 500
Payment method
The fee includes: guaranteed seat at the course, copy of
presentation material, informative literature, networking lunch
and coffee breaks, organizational assistance, certificate of
participation for your training records.
The registration fee can be paid either by
cheque or wire transfer. If paying via wire
transfer, please use the following bank
details:
EasyB S.r.l.
Via Roma, 20
24022 - Alzano Lombardo (BG) Italy
VAT: IT03633040161
Banca Popolare di Vicenza - Filiale di Nese
IBAN: IT36 B057 2853 2508 2657 0697
999
SWIFT Code: BPVIIT21820
You can also pay online via credit card
using the following link:
http://events.lsacademy.it/europe
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Please note that refunds (70% refund of the registration fee ) will only be given if cancellation is received before 21st April , 2015. Cancellations will only be valid if made in writing. Transfer of registrations
(or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the
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For additional information:
+39 045 820 26 66
[email protected]