Summary
Planning of clinical trials to support a marketing authorisation must take into account many aspects from study design to regulatory requirements and feasibility. This course aims at an overview for attendants, that have already some basic experience in the field of clinical trials. However, in many clinical settings the usual standard approach of Phase 1 to 4 and standard methodology will not be applicable. This course will provide additional hints on how to develop specific strategies adapted to such situations in a case study-based approach.
Learning Objectives
- Understand regulatory expectations
- How to tailor a study design to fit the most relevant rationale
- How to develop a strategy when a fully powered, randomized, double blinded, placebo-controlled trial is not feasible
- How to choose endpoints
- How to choose comparators
- How to select an appropriate patient population
- How to demonstrate evidence beyond safety/efficacy
Key Topics
- Criteria to choose appropriate endpoints
- Clinical relevance of an outcome vs. statistical significance, estimands
- Comparators: placebo, active, head-to head vs on top of, roll over, delayed onset, randomized withdrawal
- Label claim: homogeneous vs representative study populations
- Dose justification and flexible dosing
- How to demonstrate significant benefit, relative effectiveness, and other more specific study rationales, estimands
- How to address ethical & compliance Issues
- Methodological considerations
- Problems of limited patient populations & new diseases
- Role/problems of historical data
- Problems with blinding, open label designs
- Supportive data from outside clinical trial settings, real world evidence and registries
- Extrapolation and modelling/simulation approaches
Who should attend?
- Clinical Research Associates
- Clinical Scientists
- Clinical Operations Analysts
- Clinical Diagnostic Specialists
- Clinical Trial Managers
- Regulatory Managers & Specialists
- Quality & Compliance Associates
Past participants
- Clinical Project Scientist, Idorsia
- Sr. Director Clinical Development Leader, Teva
- Clinical Operations Manager, Gilead Sciences
- Early Development Scientist, Boehringer Ingelheim
- Director Clinical Scientist, Jenssen Biologics
- Senior Director Clinical Operations, Fresenius Kabi
- Trainee Clinical Science, Johnson & Johnson
- VP, Head of Regulatory Science, Oxford Biomedica
- Regulatory Affairs Manager, OM Pharma
- Global Trial Manager, Novo Nordisk
- Regulatory Strategist, Merck Healthcare
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.
Clinical Trial Design & Quality
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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