AGAH Workshop GPTS 2018: First-in-human trials – what you need to know.
This workshop addresses young scientists working in basic pharmacological research and other colleagues involved in biomedical research who would like to know more about early phase clinical development. First-in-human trials will be the focus of this workshop. Non-clinical prerequisites, ethical and regulatory requirements, starting dose, dose escalation rules and stopping criteria, design aspects and clinical conduct, as well as pros and cons of integrated protocols will be addressed.
|09:00||Welcome and Introduction|
|09:05 – 09:30||What is a first-in-human trial and what is so special about it?|
|09:30 – 10:00||Setting the stage: The revised EMA Guideline on early phase clinical trials|
|10:00 – 10:45||Which answers do we need from non-clinical pharmacology and toxicology prior to the first human exposure?|
|10:45 – 11:45||Break for plenary lecture GPTS|
|11:45 – 12:15||Networking lunch break|
|12:15 – 13:00||How to derive the human starting dose?|
|13:00 – 13:45||Integrated protocols: The art of combining several questions into one well-designed clinical trial|
|13:45 – 14:30||Clinical conduct of a first-in-human trial|
|14:30 – 14:45||Break|
|14:45 – 15:30||Dose escalation and stopping rules in single and multiple ascending dose parts of a FIH trial|
|15:30 – 16:15||What do Competent Authority and Ethics Comittees request to grant approval for a FIH trial?|
|16:15 – 17:00||Wrap-up and case study|
|17:30||End of Workshop|