22th AGAH Annual Meeting
“The role of the patient in human pharmacology – a changing paradigm?”
01 & 02 March 2012 in Leipzig (Germany)
It is a common assumption that toxic compounds to be developed, e.g., for oncologic indications should not be investigated in healthy subjects, hence the phase-I clinical programme is conducted in patients. Beyond that, discussion is on whether or to what extent investigational compounds can be tested in patients during clinical phase I/IIa in order to streamline the clinical development programme and achieve proof-of-concept at an earlier stage. This is also closely related to the impact of special populations in early clinical development. Important topics in this context are dedicated studies in women, paediatric populations, the elderly, ethnic groups, but also the choice of suitable patient populations for studies of medical devices and drug/device-combinations. It is widely recognized that the identification of the most suitable population for a clinical trial is an important factor on the way to stratified medicine, but the discussion about the right target population is also influenced by safety considerations, the availability of appropriate biomarkers and translational approaches and, last but not least, regulatory aspects.
In Plenary Sessions and Parallel Workshops the AGAH Annual Meeting 2012 will provide the floor for a com-prehensive exchange of experience and opinion on the future of the healthy subject in clinical trials in times where rapid proof-of-concept is of utmost importance. Full sessions are dedicated to population issues in oncology studies and the best way to get to rapid proof-of-concept.