Clinical Trial Design & Quality
Clinical Trial Design & Quality

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

  • 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 
  • 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 

Clinical Trial Design & Quality

SYM180O
Regular price €2.650,00
Unit price
per 
Dr. Karl-Heinz Huemer

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.

Dr. Simon Day

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

Group discounts available upon request - contact us.

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

  • 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 
  • 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 

"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

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.

Medical-Devices-Certificate-Course

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