Clinical Epidemiology – Research Methods in Medicine – Foundations of Medical Knowledge

5-6-7-12-13 March 2018
Milan

Teacher: Paolo Bruzzi, Ospedale San Martino, Genova

Dates: 5-6-7-12-13 March 2018

The general objective of the course is to provide participants with the skills and competences that are needed to review/prepare a clinical research project, or to write/review an article reporting the results of a clinical study.

More specifically, its aims include:

  • to provide a glossary of the terms and concepts most commonly used in clinical studies
  • to offer a general perspective on the methods used in biomedical research and an insight into some of its technical aspects
  • to illustrate the weaknesses and critical aspects of these methods, as currently applied
  • to discuss modern developments in the methodology of clinical trials
  • to offer a conceptual framework for modern medical knowledge and to illustrate the true meaning of evidence-based medical decision 
Timetable
10.00-13.00
Lesson Argument
  • Medicine & Statistics
  • Traditional Medical Thinking - Medical Determinism and its crisis
  • How to evaluate the effects of a treatment
Lesson Location
Gold Room
Timetable
14.30-17.30
Lesson Argument
  • Phases of Clinical Trials – Activity vs Efficacy
  • Clinical Trial – The perfect study
  • Study Design, Superiority, Equivalence and non-inferiority
Lesson Location
Gold Room
Timetable
9.00-12.30
Lesson Argument

Main Features of the Randomised Clinical trial

Endpoint and Masking
Randomization
Intention to treat
Statistical Plan

Lesson Location
Gold Room
Timetable
14.00-16.00
Lesson Argument

How to interpret a clinical trial

Internal Validity
External validity
Internal consistency, Plausibility, External Coherence, Relevancegol

Lesson Location
Gold Room
Timetable
16.00-18.00
Lesson Argument

Randomised Trials, Uncontrolled Trials and Observational studies

Lesson Location
Gold Room
Timetable
9.00-12.30
Lesson Argument
  • The Statistical Plan of a clinical study (2)
  • Multiplicity (Multiple Endpoints/Interim Analyses/Subgroup Analyses)
  • The myth of Precision Medicine
Lesson Location
Gold Room
Timetable
14.00-17.00
Lesson Argument
  • Evaluation of Risk and Prediction of Efficacy of a treatment
  • Surrogate endpoints and markers
Lesson Location
Gold Room
Timetable
10.00-13.00
Lesson Argument
  • Bayesian Statistics
  • Clinical Studies in rare diseases
Lesson Location
Gold Room
Timetable
14.30-17.30
Lesson Argument
  • Observational Studies – Ecological vs Analytic Studies
  • Types and Main features of observational studies
  • Real World Evidence
Lesson Location
Gold Room
Timetable
9.00-13.00
Lesson Argument
  • Evidence Based Medicine – General Concepts
  • Systematic Reviews/Pooled analyses
  • Medical Decision
Lesson Location
Gold Room
Timetable
14.00-17.00
Lesson Argument
  • New Study Designs

Umbrella – Basket Trials
Adaptive Studies

  • A new concept: The estimands
  • Case-Studies
Lesson Location
Gold Room