Clinical Development Methodology, Biostatistics, and Clinical Data management

Principles of clinical trial methodology, especially in vaccine development; basic concepts of statistics and data management for clinical trials.

Module's directors

Dr. Uwe Nicolay

Head Biostatistics & Statistical Reporting Site Head Development Marburg
GSK, Marburg, Germany

Giovanni Della Cioppa, MD, MPharma

Head R&D Centre Italy
GSK, Siena , Italy

Prof. Stefania Rossi

Researcher of Public Health
Dept. of Molecular and Developmental Medicine, University of Siena, Italy


Overview of the clinical development: 

 Clinical trial methodology and protocol development: 

Vaccine trial methodology: 

Statistical methodology for clinical trials: 

Alignment of protocol, data collection and reports. 
Clinical Data Management: 

See the lessons' list

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Lessons' List

Introduction to Module V, parts 1 & 2 - clinical study methodology
Variability of biological phenomena and measurements errors
Distinctive aspects of a biomedical study
The fallacy of “before-after” comparisons in uncontrolled studies
The randomized blinded study as an instrument to reduce bias
The choice of treatments
The choice of the sample
Defining the treatment effect
Experimental designs I: parallel group design and other designs with comparison between subjects
Experimental designs II: cross-over design and other designs with comparisons within subjects
Experimental designs III: factorial designs and uncontrolled designs in special situations
Experimental designs IV: dose escalation, dose titration, simultaneous treatment, single patient designs
Experimental designs V: equivalence, non-inferiority, interim analyses and adaptive designs
Common methodological pitfalls in clinical trials
Conducting clinical trials in poor countries: what to keep in mind when designing the protocol and other study documents
Peculiarities of vaccine development: Phase 1-4 in vaccine development
Human challenge models to demonstrate the protective effect of new vaccines
Clinical Serology
Vaccine supply management
Introduction to module V, Part 3 – Biostatistics
Lesson 1Descriptive statistics
Inferential statistics
Randomization/ power and sample size calculation
Analysis of safety data
ANOVA, Regression Analysis, ANCOVA
Bayesian inference
Interim Analysis, sequential testing, adaptive design
Practical exercises: How to read and interpret SAS tables
Statistical considerations for bioassay development
Validation of serological assays for clinical testing
Vaccine Efficacy / concept, design types
Introduction to module V, part 4: clinical data management
Design of Case Report Forms (CRFs) and edit checks
Electronic clinical data systems, validation, security and data privacy
Planning data management activities for a clinical trial
Standards and CDISC – SDTM and ADaM
Electronic Data Capture (EDC) training
Clinical database design, building and testing
Innovations in electronic data systems
Self-directed study / Assigned work: creation of CRF. review of a data management plan, hands-on use of EDC

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