AGAH will realise a workshop on early clinical trials in oncology, held in Frankfurt on February 20th, 2015.
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 require-ments, 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 bioequiva-lence 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 specific-ities. 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 experi-enced experts will present the relevant aspects to be ob-served and will share their specific experience with you.
For more details please visit AGAH homepage