CROS Academy: European Course Schedule Update

CROS Academy is the training branch of CROS NT which offers training courses on biostatistics topics. Below find an update of our European course schedule:

Analyzing progress

Statistical Considerations in Oncology Studies (German language course)
Statistische Überlegungen in onkologischen Studien
28, April 2015 | Hotel Eden Wolff – München, Deutschland

Kursbroschüre

Die Entwicklung onkologischer Arzneimittel benötigt durchschnittlich sieben Jahre in der klinischen Bewertung mit  einer entmutigenden Erfolgsquote: nur 7% der Entwicklungsprodukte, die in die Phase I eintreten erreichen eine Marktzulassung.  Da die Onkologie ein einzigartiger Therapiebereich ist, können Biostatistiker  durch Unterstützung beim Design der Studie den Arzneimittelentwicklern helfen, sich schon früh im Forschungsprozess auf die richtige Dosis für die richtigen Patienten zu fokussieren.

Der Kurs ist unterteilt in zwei Abschnitte: Teil I konzentriert sich auf die Voraussetzungen für eine erfolgreiche Phase I und Phase II und Teil II diskutiert Methoden zur frühen Beurteilung der Erfolgsaussicht in Phase II und III einschließlich der Anwendung adaptiver Studiendesigns.

Understanding Study Design & Successful Sample Size Calculation (Italian-language course)
Comprendere i Concetti Statistici negli Studi Clinici & il Calcolo del Campione
13 maggio 2015 | Hotel Melià – Milano, Italia

Brochure del Corso

Questo corso è dedicato ai professionisti nell’ambito degli studi clinici che vorrebbero comprendere gli aspetti critici di successo nel disegno di uno studio ed il calcolo del campione da un punto di vista statistico. Durante il corso, le varie fasi di sviluppo di un farmaco saranno presentate e verranno introdotti i diversi metodi statistici possibili in uno studio clinico. La seconda parte del corso si focalizzerà sulla stima del campione ed il modo in cui viene calcolato, ed inoltre, su come interpretare l’importanza di questo fattore essenziale.

Understanding the Statistical Elements of a Study Protocol – for Non-Statisticians
01 June 2015  | Copenhagen, Denmark
*Please note the date change due to bank holiday in Denmark

Course Brochure

The biostatistician plays a crucial role in the process of both drug and device development – from protocol design to data analysis and regulatory submissions. The biostatistician defines study endpoints, sample size calculation, interim analysis monitoring plans, hypothesis testing and procedures and the overall Statistical Analysis Plan.

This course is offered to clinical trial professionals who wish to comprehend the role of biostatistics and statisticians in clinical trials. The course aims to enhance one’s understanding of basic statistical principles as well as the statistician’s view on clinical trial aspects.

Introduction to Adaptive Trial Design
03 June 2015 | Novotel Paris Les Halles – Paris, France

Course Brochure

Introduction to Adaptive Trial Design
09 June 2015 | Vienna, Austria

Course Brochure

Adaptive Trial Design offers greater flexibility and the possibility to modify a study in progress based on new information derived from accumulated data. Studies have demonstrated that between 20-30% of clinical studies are using adaptive designs and the implications of adaptive designs – such as sample size recalculation or early study termination – could potentially save Sponsors between €75-€150 million euros per year.

Participants of this course will be able to discuss adaptations possible in study design and understand decision rules. Choosing the appropriate statistical method and type of design is crucial to success and allows biostatisticians to make go/no-go decisions.