Learning and Confirming Trials: Finding and Confirming the Right Dose

Aim

The planning, the choice of different trial designs, the randomisation modes and the choice of endpoints are discussed. The different aspects of the conduct of a trial, i.e. study monitoring, principles of good clinical practice (GCP), adverse event monitoring (risk/benefit assessment) and data management are demonstrated. A basic introduction to biostatistics is given.

Location & Organization

Organizer

ECPM - European Center of Pharmaceutical Medicine, University of Basel

Faculty / Teachers

Douglas G. Altman, Cancer Research UK Med. Stat. Group, Headington, Gerd Antes, Albert-Ludwigs-Universität, Freiburg i.Br., Marc Buyse, ID2 International, Ottignies Louvain-la-Neuve, Sheelagh Corcoran, Brookwood International Academy, Guildford, Julian Gray, Consultant, Inzlingen, Andrew P. Grieve, Pfizer Central Research, Sandwich, Jean-Louis Imbs, Louis Pasteur University, Strasbourg, Markus Kiefer, Novartis Pharma AG, Basel, Peter Kleist, PFC Pharma Focus AG, Volketswil, Xavier Lataste, Novartis Pharma AG, Basel, Richard C. Meibach, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Prof. Giovanni Maio, Albert-Ludwigs-Universität, Freiburg i.Br., Willi Maurer, Novartis Pharma AG, Basel, Norbert Neumann, F. Hoffmann-La Roche AG, Basel, Carl C. Peck, ACDRS and Center for Drug Development Science, Washington, DC, Kurt Pfister, PFC Pharma Focus AG, Volketswil, Martin Schumacher, Klinikum der Albert-Ludwigs-Uni., Freiburg i.Br., Eckart W. Schwarz, GlaxoSmithKline, Rixensart, Stephen J. Senn, University of Glasgow, Glasgow, Thomas D. Szucs, ECPM, Basel, Frank Wells, Consultant, Chapel St. Mary, Beat Widler, F. Hoffmann-La Roche AG, Basel, Janet Wittes, Statistics Collaborative, Washington, DC

Location / venue

Pharmacenter, University of Basel

Costs

ECPM Course incl. six modules 11’500 CHF; for members of the University 4’000 CHF

Timing & Workload

Duration Four days
ECTS points 30 (see remarks)
 

Teaching methods used

Teaching incl. case studies

Examination yes

Criteria

Is the course taught in English? yes
Is documentation available? (book, syllabus)? yes
Is the course open for external researchers? yes

Remarks

This is a Base Module in the ECPM course for post graduates. Costs and ECTS points listed are for the total ECPM master program. The complete program consists of six four-day modules over two years.

More Information

http://www.ecpm.ch