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
- Tailoring study design to align with the most relevant rationale
- Developing strategies when a fully powered, randomized, double-blind, placebo-controlled trial is not feasible
- Selecting appropriate endpoints, comparators, and patient populations
- Demonstrating evidence beyond safety and efficacy
Key Topics
- Choosing and justifying study endpoints
- Clinical relevance vs. statistical significance (estimands)
- Comparator selection: placebo, active, head-to-head, roll-over, delayed onset, randomized withdrawal
- Study population considerations: homogeneous vs. representative for label claims
- Dose justification and flexible dosing strategies
- Demonstrating significant benefit, relative effectiveness, and study rationales
- Ethical and compliance challenges
- Methodological considerations and limitations
- Addressing challenges with limited patient populations and emerging diseases
- Role and limitations of historical data
- Blinding challenges and open-label study designs
- Utilizing real-world evidence, registries, and supportive data outside clinical trials
- Extrapolation, modeling, and 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
- 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: Best Practices for Designing Robust Studies
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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