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 |
| Hypotheses |
| Inferential statistics |
| Randomization/ power and sample size calculation |
| Multiplicity |
| 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 |
| Meta-analysis |
| 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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