€320 – €840

Intro to Statistical Methodology for Efficient and Compliant Trials

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Biostatistics plays a crucial role in the efficiency and success of a clinical trial. The biostatistician plays an important role in study and protocol design and choosing the appropriate method of analysis in order to comply with regulatory requirements, ensure patient safety and secure quality results. Rescue studies are often needed due to poor trial design and inconsistency with endpoints and a failure to understand regulatory requirements and feedback in this area. Sponsors spend millions annually on rescue studies to “overcome protocol design flaws and patient recruitment difficulties”.

The publication in 1998 of ICH E9 guidance on Statistical Principles in Clinical Trials brought a degree of clarity and harmonization to the statistical requirements of the major regulatory authorities. Since that time the FDA and EMA have issued a further twelve guidance documents and have developed certain standard approaches which are not well-documented.

In this course a statistician experienced in interacting with both the FDA and EMA will identify the key issues of concern to regulatory authorities and will focus on ways to design and analyse clinical trials to avoid or minimize the impact of these issues.

Course Objectives

  • Understand basic statistical concepts and different methodologies

  • Comprehend the main statistical issues of concern for regulators

  • Learn to work with statisticians to identify ways to design and analyze trials to avoid issues

For Whom is this course designed?

The course will be suitable for anyone with basic knowledge of statistical issues in clinical drug development (however no statistical training is required), such as:

  • Medical Directors and Medical Affairs professionals

  • Heads of Clinical Operations with limited statistical knowledge

  • Clinical professionals in Pharmaceutical, Biotechnology or Medical Device Companies

  • Regulatory professionals in Pharmaceutical, Biotechnology or Medical Device Companies

  • Biostatisticians with limited knowledge of regulatory activities

  • Outsourcing managers


08:30 - 09:00: Welcome and Registration

09:00 - 09:45: Regulatory Guidance on Statistical Topics

09:45 - 10:30: Objectives of a Study - Primary Outcome, Estimands and the Problem of Multiplicity

10:30 - 10:45: Morning Coffee Break

10:45 - 11:30: Dealing with Multiplicity

11:30 - 12:30: Non-Inferiority Trials - Choice of Margin

12:30 - 14:00: Lunch

14:00 - 14:45: Analysis Populations- what patients do we include?

14:45 - 15:30: How to handle missing data - including sensitivity analysis

15:30 - 15:45: Afternoon Coffee Break

15:45 - 16:30: Subgroup Analyses

16:30 - 17:15: A look at adaptive trial design

17:15 - 18:00: Questions and Answers

THE INSTRUCTOR - Thomas Zwingers

Thomas Zwingers is Head of Statistical Consultancy for CROS NT, a global CRO with offices in the UK, Germany, Italy and the US. In his current role, Thomas provides pharma, biotech and medical device companies with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submission, and has presented statistical findings to the European Medicines Agency on numerous occasions. Thomas has been working in the clinical trial environment since 1980 in project team management and statistical analysis. He specializes in statistical analysis and reporting with particular expertise in Adaptive Trial Design and Non-Inferiority Trials.

Prior to joining CROS NT, Thomas has an independent statistical consultant who ran his own biometrics CRO in Germany for over 20 years. During this time, he gained a considerable amount of experience in Dermatology, Respiratory and Oncology studies, and has particular expertise in applying adaptive designs to oncology trials.


CROS NT proudly supports Wings For Life Fundthroughout 2017. In occasion of this course, CROS Academy will donate 20 EUR for every participant in honor of Wings For Life.

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