Venue: DAS SPENERHAUS, Frankfurt am Main
Early clinical trials in oncology are challenging for all parties involved: sponsors, investigators and patients. After decades of drug development with highly toxic drugs and identification of the maximal tolerated dose as the major objective, targeted therapies come in the focus redefining benefit/risk ratio in this field. Nevertheless, an adequate balance between scientific planning, regulatory requirements, the need to minimize burden and to maximize benefit for the study participants is difficult to find.
The basic principles of course are identical to “classical” drug development, but all types of early clinical studies i.e. First-into-men, PK-studies, bioavailability and bioequivalence trials, MTD and dose finding studies, even DDI and QTc trials require a specific knowledge and assessments. From Inclusion-/Exclusion criteria to design development – everything appears to be “somewhat different”.
The workshop has been set-up to carve out these specificities. It is intended for participants from industry- and CRO side as well as for regulators and investigators involved in oncological drug development. A group of highly experienced experts will present the relevant aspects to be observed and will share their specific experience with you.