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  1. Courses

MED0563 - CLINICAL RESEARCH METHODOLOGY

courses
ID:
MED0563
Duration (hours):
92
CFU:
2
Located in:
Varese - Università degli Studi dell'Insubria
Year:
2025
  • Overview
  • Syllabus
  • Degrees
  • People

Overview

Date/time interval

Secondo Trimestre (02/03/2026 - 01/04/2026)

Syllabus

Course Objectives

The course aims to introduce students to the methodological aspects connected with applied research in the clinical field. The lessons of the evidence-based medicine module focus in particular on the concept of "evidence-based medicine" and its application, in particular in aspects related to study design in randomized clinical trials. The lessons of the medical statistics module take up some concepts from the first year basic course, linked to the use of statistical inference for the verification of clinical hypotheses, and delve into some methodologies linked to the statistical analysis of clinical studies, including observational ones.

Expected learning outcomes:
At the end of the course, the student will be able to:
Evidence-based medicine module:
1. Provide the basis for understanding study designs;
2. Recognize the fundamental elements of the critical appraisal of a scientific article, in particular connected with the study design;
3. Know how to recognize and classify scientific evidence in the medical field;
4. Know the methodology of the guidelines

Medical statistics module:
1. Correctly interpret the results associated with inferential statistics, such as p-values ​​and 95% confidence intervals;
2. Know the main statistics used in experimental clinical studies;
3. Know the critical issues associated with observational clinical studies, and the statistical analysis tools appropriate for that context;
4. Know and correctly interpret the methods of analysis of the time to the occurrence of an event of interest (survival analysis)

Course Prerequisites

Evidence-based medicine module: none.
Medical statistics module: contents of the first year basic course

Assessment Methods

The exam requires students, in groups of 3 or 4, to choose a paper taken from the scientific literature and relating to a clinical study (either a trial or an observational study) in the medical field, and to prepare a short presentation (15-20 minutes) of the same. The presentation must summarize the fundamental elements of the study itself, and in particular the question/objective of the study, the analytical design, the statistical analysis, the interpretation of the results, and the discussion of the same, including its limitations. The groups will then discuss the presentation on the day of the exam, dividing it among the various components; at the end there will be a couple of minutes for a short discussion with the teachers. The exam defines the students' level of knowledge of the concepts seen in class (30%), and their ability to apply them to the critical understanding of scientific literature in the medical field (70%).
Foreign students (Erasmus) can prepare the slides and give their oral presentation in English.

Course Language

Italian. Foreign students (Erasmus) can take the oral exam in English

Degrees

Degrees

MEDICINE AND SURGERY 
Single-cycle Master’s Degree (6 Years)
6 years
No Results Found

People

People (2)

DONADINI MARCO PAOLO
AREA MIN. 06 - Scienze mediche
Settore MEDS-05/A - Medicina interna
LS7_10 - Preventative and prognostic medicine - (2024)
Gruppo 06/MEDS-05 - MEDICINA INTERNA
Docenti di ruolo di IIa fascia
VERONESI GIOVANNI
Goal 3: Good health and well-being
Settore MEDS-24/A - Statistica medica
LS2_14 - Biostatistics - (2020)
AREA MIN. 06 - Scienze mediche
Goal 10: Reduced inequalities
Gruppo 06/MEDS-24 - STATISTICA MEDICA, IGIENE GENERALE E APPLICATA E SCIENZE INFERMIERISTICHE GENERALI, CLINICHE, PEDIATRICHE E OSTETRICO-GINECOLOGICHE E NEONATALI
LS7_8 - Epidemiology and public health - (2020)
Goal 13: Climate action
Docenti di ruolo di IIa fascia
No Results Found
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