Course Description

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 clinical trials online course will provide additional hints on how to develop specific strategies adapted to such situations in a case study-based approach.

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
Data collection, analysis, and interpretation
Extrapolation and modelling/simulation approaches

Learning Objectives

Understand regulatory expectations – a wide range of topics covered: from design to regulatory compliance
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

Who should attend?

Past participants

Our online training experience includes

FAQ

Clinical Trial Design & Quality

6 - 7 June 2024, Live Online Training

€1.650,00

Unit price: per

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 and medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies.

START TIMES

2:00 PM Vienna time

1:00 PM London time

8:00 AM New York time

5:00 AM Los Angeles time

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Course Description

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
Data collection, analysis, and interpretation
Extrapolation and modelling/simulation approaches

Learning Objectives

Understand regulatory expectations – a wide range of topics covered: from design to regulatory compliance
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

Who should attend?

Past participants

Our online training experience includes

FAQ

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim