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 • 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 CROS NT Statistical Scientific Board, 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 09:30 – 09:15 Registration 09.15 – 10.00 Why is Oncology special - introduction 09:15 – 10:00 Study Designs in Oncology research 10:00 – 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: £ 400 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, 25 – 24002 Alzano Lombardo (BG) Italy VAT: 03633040161 Banca Popolare di Vicenza – Filiale di Nese IBAN: IT27H0572852521820570697999 SWIFT Code: BPVIIT21820 You can also pay online via credit card using the following link: http://events.lsacademy.it/europe PLEASE FILL IN AND SEND VIA E-MAIL TO: [email protected] Cheque No. Name Company Name Address City Tel. E-mail Special dietary requests Bank Transfer Online Surname Job title Post Code Fax. INVOICING DETAILS: Company name Address Mail address (if different) City VAT Number Postal Code Terms & Conditions Cancellation 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 advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities. Date Signature For additional information: +39 045 820 26 66 [email protected]
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